A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
1 other identifier
interventional
10,355
36 countries
993
Brief Summary
The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD. Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid \[ICS\]/ Long-acting Muscarinic Receptor Antagonists \[LAMA\])/ Long Acting Beta-Agonist \[LABA\] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone. These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year. Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler). In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period. Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5 mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2014
Typical duration for phase_3
993 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2014
CompletedFirst Posted
Study publicly available on registry
June 16, 2014
CompletedStudy Start
First participant enrolled
June 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 17, 2017
CompletedResults Posted
Study results publicly available
October 10, 2018
CompletedOctober 10, 2018
August 1, 2018
3 years
June 12, 2014
July 6, 2018
September 11, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI
The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed. Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death). Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death. Analysis performed using a generalized linear model assuming a negative binomial distribution. ITT population was used which comprised of all randomized participants, excluding those who were randomized in error. Only those participants with non-missing co-variates were included in the analysis.
Up to Week 52
Secondary Outcomes (6)
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI
Baseline and Week 52
Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI
Baseline and Week 52
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Up to Week 52
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter
Up to Week 52
Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline
Up to Week 52
- +1 more secondary outcomes
Study Arms (3)
fluticasone furoate/umeclidinium bromide/vilanterol
EXPERIMENTALEligible Subjects completing 2-weeks run-in period will receive FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg QD (morning) for a period of 52 weeks via DPI
fluticasone furoate/vilanterol
EXPERIMENTALEligible Subjects completing 2-weeks run-in period will receive FF/VI 100 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI)
umeclidinium bromide/vilanterol
EXPERIMENTALEligible Subjects completing 2-weeks run-in period will receive UMEC/VI 62.5 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI
Interventions
FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg
VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg
Eligibility Criteria
You may qualify if:
- Informed Consent: A signed and dated written informed consent prior to study participation
- Type of subject: Outpatient
- Age: Subjects 40 years of age or older at Visit 1
- Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, \> 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
- COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
- Smoking History: Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at screening (visit 1) \[number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)\]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history
- Severity of COPD symptoms: A score of \>=10 on the COPD Assessment Test (CAT) at screening
- Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of \<0.70 at Screening
- Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible
- History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 \<50% predicted normal and a documented history of \>= 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% \<=FEV1 \< 80% predicted normal and a documented history of \>= 2 moderate exacerbations or a documented history of \>=1 severe COPD exacerbation (hospitalized) in the previous 12 months. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable
- Liver function tests: alanine aminotransferase (ALT) \<2x upper limit of normal (ULN); alkaline phosphatase \<=1.5xULN; bilirubin \<=1.5xULN (isolated bilirubin \>1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%)
You may not qualify if:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
- Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD
- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
- Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus \[HIV\], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
- Other Respiratory tract infections that have not resolved at least 7 days prior to screening
- Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz \[BfS\])
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
- Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
- Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure
- Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate \>120 beats per minute); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTcF) \>=500 milliseconds (msec) in patients with QRS \<120 msec and QTcF \>=530 msec in patients with QRS \>=120 msec
- Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (998)
GSK Investigational Site
Athens, Alabama, 35611, United States
GSK Investigational Site
Birmingham, Alabama, 35215, United States
GSK Investigational Site
Birmingham, Alabama, 35216, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Florence, Alabama, 35630, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Mobile, Alabama, 36608, United States
GSK Investigational Site
Muscle Shoals, Alabama, 35662, United States
GSK Investigational Site
Sheffield, Alabama, 35660, United States
GSK Investigational Site
Chandler, Arizona, 85284, United States
GSK Investigational Site
Flagstaff, Arizona, 86001, United States
GSK Investigational Site
Glendale, Arizona, 85306, United States
GSK Investigational Site
Peoria, Arizona, 85381, United States
GSK Investigational Site
Phoenix, Arizona, 85018, United States
GSK Investigational Site
Phoenix, Arizona, 85032, United States
GSK Investigational Site
Tucson, Arizona, 85723, United States
GSK Investigational Site
Tucson, Arizona, 85724-5023, United States
GSK Investigational Site
Tucson, Arizona, 85745, United States
GSK Investigational Site
Arcadia, California, 91007, United States
GSK Investigational Site
Bakersfield, California, 93301, United States
GSK Investigational Site
Chula Vista, California, 91910, United States
GSK Investigational Site
Encinitas, California, 92024, United States
GSK Investigational Site
Escondido, California, 92025, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Long Beach, California, 90808, United States
GSK Investigational Site
Long Beach, California, 90822, United States
GSK Investigational Site
Mission Hills, California, 91345, United States
GSK Investigational Site
Modesto, California, 95350, United States
GSK Investigational Site
Newport Beach, California, 92663, United States
GSK Investigational Site
Palo Alto, California, 94304, United States
GSK Investigational Site
Reseda, California, 91335, United States
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Sacramento, California, 95821, United States
GSK Investigational Site
San Diego, California, 92117, United States
GSK Investigational Site
Santa Ana, California, 92705, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Torrance, California, 90505, United States
GSK Investigational Site
Tustin, California, 92780, United States
GSK Investigational Site
Upland, California, 91786, United States
GSK Investigational Site
Vista, California, 92083, United States
GSK Investigational Site
Boulder, Colorado, 80301, United States
GSK Investigational Site
Colorado Springs, Colorado, 80907, United States
GSK Investigational Site
Fort Collins, Colorado, 80538, United States
GSK Investigational Site
Golden, Colorado, 80401, United States
GSK Investigational Site
Danbury, Connecticut, 06810, United States
GSK Investigational Site
Hartford, Connecticut, 06105, United States
GSK Investigational Site
New Haven, Connecticut, 06520, United States
GSK Investigational Site
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Waterbury, Connecticut, 06708, United States
GSK Investigational Site
West Haven, Connecticut, 06516, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Boynton Beach, Florida, 33436, United States
GSK Investigational Site
Brandon, Florida, 33511, United States
GSK Investigational Site
Celebration, Florida, 34747, United States
GSK Investigational Site
Clearwater, Florida, 33759, United States
GSK Investigational Site
Clearwater, Florida, 33765-2616, United States
GSK Investigational Site
Daytona Beach, Florida, 32117, United States
GSK Investigational Site
DeLand, Florida, 32720, United States
GSK Investigational Site
Edgewater, Florida, 32132, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33306, United States
GSK Investigational Site
Fort Myers, Florida, 33908, United States
GSK Investigational Site
Gainesville, Florida, 32608, United States
GSK Investigational Site
Hollywood, Florida, 33024, United States
GSK Investigational Site
Jacksonville, Florida, 32204, United States
GSK Investigational Site
Jacksonville, Florida, 32205, United States
GSK Investigational Site
Jacksonville, Florida, 32207, United States
GSK Investigational Site
Jacksonville, Florida, 32209, United States
GSK Investigational Site
Jacksonville, Florida, 32216, United States
GSK Investigational Site
Leesburg, Florida, 34748, United States
GSK Investigational Site
Loxahatchee Groves, Florida, 33470, United States
GSK Investigational Site
Maitland, Florida, 32751, United States
GSK Investigational Site
Miami, Florida, 33015, United States
GSK Investigational Site
Miami, Florida, 33137, United States
GSK Investigational Site
New Port Richey, Florida, 34652, United States
GSK Investigational Site
Orlando, Florida, 32825, United States
GSK Investigational Site
Oviedo, Florida, 32765, United States
GSK Investigational Site
Pembroke Pines, Florida, 33027, United States
GSK Investigational Site
Pensacola, Florida, 32503, United States
GSK Investigational Site
Ponte Vedra Beach, Florida, 32081, United States
GSK Investigational Site
Port Charlotte, Florida, 33952, United States
GSK Investigational Site
Port Charlotte, Florida, 33980, United States
GSK Investigational Site
Port Orange, Florida, 32127, United States
GSK Investigational Site
Sarasota, Florida, 34239, United States
GSK Investigational Site
St. Petersburg, Florida, 33704, United States
GSK Investigational Site
Tampa, Florida, 33603, United States
GSK Investigational Site
Adairsville, Georgia, 30103, United States
GSK Investigational Site
Athens, Georgia, 30606, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Columbus, Georgia, 31904, United States
GSK Investigational Site
Conyers, Georgia, 30094, United States
GSK Investigational Site
Decatur, Georgia, 30033, United States
GSK Investigational Site
Duluth, Georgia, 30096, United States
GSK Investigational Site
Gainesville, Georgia, 30501, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Rincon, Georgia, 31326, United States
GSK Investigational Site
Woodstock, Georgia, 30189, United States
GSK Investigational Site
Coeur d'Alene, Idaho, 83814, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Elk Grove Village, Illinois, 60007, United States
GSK Investigational Site
Gillespie, Illinois, 62033, United States
GSK Investigational Site
Hines, Illinois, 60124, United States
GSK Investigational Site
O'Fallon, Illinois, 62269, United States
GSK Investigational Site
Oak Park, Illinois, 60302, United States
GSK Investigational Site
Quincy, Illinois, 62301, United States
GSK Investigational Site
Winfield, Illinois, 60190, United States
GSK Investigational Site
Evansville, Indiana, 47714, United States
GSK Investigational Site
Franklin, Indiana, 46131, United States
GSK Investigational Site
Greenfield, Indiana, 46140, United States
GSK Investigational Site
Muncie, Indiana, 47303, United States
GSK Investigational Site
Council Bluffs, Iowa, 51503, United States
GSK Investigational Site
Iowa City, Iowa, 52242, United States
GSK Investigational Site
Olathe, Kansas, 66061, United States
GSK Investigational Site
Topeka, Kansas, 66606, United States
GSK Investigational Site
Wichita, Kansas, 67218, United States
GSK Investigational Site
Fort Mitchell, Kentucky, 41017, United States
GSK Investigational Site
Louisville, Kentucky, 40218, United States
GSK Investigational Site
Paducah, Kentucky, 42003, United States
GSK Investigational Site
Crowley, Louisiana, 70526, United States
GSK Investigational Site
Lafayette, Louisiana, 70508, United States
GSK Investigational Site
New Orleans, Louisiana, 70112, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
New Orleans, Louisiana, 70119, United States
GSK Investigational Site
Shreveport, Louisiana, 71103, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Bangor, Maine, 04401, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Hollywood, Maryland, 20636, United States
GSK Investigational Site
Fall River, Massachusetts, 02720, United States
GSK Investigational Site
North Dartmouth, Massachusetts, 02747, United States
GSK Investigational Site
Pittsfield, Massachusetts, 01201, United States
GSK Investigational Site
Worcester, Massachusetts, 01608, United States
GSK Investigational Site
Ann Arbor, Michigan, 48106, United States
GSK Investigational Site
Southfield, Michigan, 48034, United States
GSK Investigational Site
Troy, Michigan, 48085, United States
GSK Investigational Site
Duluth, Minnesota, 55805, United States
GSK Investigational Site
Edina, Minnesota, 55435, United States
GSK Investigational Site
Fridley, Minnesota, 55432, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
GSK Investigational Site
Rochester, Minnesota, 55905, United States
GSK Investigational Site
Saint Paul, Minnesota, 55130, United States
GSK Investigational Site
Woodbury, Minnesota, 55125, United States
GSK Investigational Site
Jackson, Mississippi, 39202, United States
GSK Investigational Site
Chesterfield, Missouri, 63017, United States
GSK Investigational Site
Kansas City, Missouri, 64128, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Butte, Montana, 59701, United States
GSK Investigational Site
Missoula, Montana, 59808, United States
GSK Investigational Site
Fremont, Nebraska, 68025, United States
GSK Investigational Site
Grand Island, Nebraska, 68803, United States
GSK Investigational Site
Lincoln, Nebraska, 68506, United States
GSK Investigational Site
Omaha, Nebraska, 68131, United States
GSK Investigational Site
Omaha, Nebraska, 68134, United States
GSK Investigational Site
Las Vegas, Nevada, 89106, United States
GSK Investigational Site
Reno, Nevada, 89503, United States
GSK Investigational Site
Marlton, New Jersey, 08053, United States
GSK Investigational Site
Moorestown, New Jersey, 08057, United States
GSK Investigational Site
Neptune City, New Jersey, 07753, United States
GSK Investigational Site
Albuquerque, New Mexico, 87108, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Bronxville, New York, 10708, United States
GSK Investigational Site
New York, New York, 10009, United States
GSK Investigational Site
New York, New York, 10016, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
The Bronx, New York, 10457, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
GSK Investigational Site
Asheville, North Carolina, 28801, United States
GSK Investigational Site
Calabash, North Carolina, 28467, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Charlotte, North Carolina, 28262, United States
GSK Investigational Site
Charlotte, North Carolina, 28277, United States
GSK Investigational Site
Durham, North Carolina, 27710, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Gastonia, North Carolina, 28054, United States
GSK Investigational Site
Greensboro, North Carolina, 27403, United States
GSK Investigational Site
Hendersonville, North Carolina, 28739, United States
GSK Investigational Site
Huntersville, North Carolina, 28078, United States
GSK Investigational Site
Lexington, North Carolina, 27292, United States
GSK Investigational Site
Mooresville, North Carolina, 28117, United States
GSK Investigational Site
Shelby, North Carolina, 28150, United States
GSK Investigational Site
Shelby, North Carolina, 28152, United States
GSK Investigational Site
Tabor City, North Carolina, 28463, United States
GSK Investigational Site
Whiteville, North Carolina, 28472, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Winston-Salem, North Carolina, 27103, United States
GSK Investigational Site
Canton, Ohio, 44718, United States
GSK Investigational Site
Cincinnati, Ohio, 45220, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Cincinnati, Ohio, 45245, United States
GSK Investigational Site
Columbus, Ohio, 43213, United States
GSK Investigational Site
Dayton, Ohio, 45459, United States
GSK Investigational Site
Marion, Ohio, 43302, United States
GSK Investigational Site
Middleburg Heights, Ohio, 44130, United States
GSK Investigational Site
Toledo, Ohio, 43606, United States
GSK Investigational Site
Toledo, Ohio, 43617, United States
GSK Investigational Site
Wooster, Ohio, 44691, United States
GSK Investigational Site
Corvallis, Oregon, 97330, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Portland, Oregon, 97220, United States
GSK Investigational Site
Portland, Oregon, 97225, United States
GSK Investigational Site
Portland, Oregon, 97239, United States
GSK Investigational Site
Downingtown, Pennsylvania, 19335, United States
GSK Investigational Site
Doylestown, Pennsylvania, 18901, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Johnstown, Pennsylvania, 15905, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19107, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19140, United States
GSK Investigational Site
Philadelphia, Pennsylvania, 19142, United States
GSK Investigational Site
Phoenixville, Pennsylvania, 19460, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243, United States
GSK Investigational Site
Tipton, Pennsylvania, 16684, United States
GSK Investigational Site
Wyomissing, Pennsylvania, 19610, United States
GSK Investigational Site
East Providence, Rhode Island, 02914, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Columbia, South Carolina, 29204, United States
GSK Investigational Site
Columbia, South Carolina, 29209, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Fort Mill, South Carolina, 29707, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Gaffney, South Carolina, 29341, United States
GSK Investigational Site
Greenville, South Carolina, 29615, United States
GSK Investigational Site
Mt. Pleasant, South Carolina, 29464, United States
GSK Investigational Site
Rock Hill, South Carolina, 29732, United States
GSK Investigational Site
Seneca, South Carolina, 29678, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Rapid City, South Dakota, 57702, United States
GSK Investigational Site
Sioux Falls, South Dakota, 57108, United States
GSK Investigational Site
Chattanooga, Tennessee, 37404, United States
GSK Investigational Site
Hendersonville, Tennessee, 37075, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Corsicana, Texas, 75110, United States
GSK Investigational Site
Edinburg, Texas, 78539, United States
GSK Investigational Site
Fort Worth, Texas, 76104, United States
GSK Investigational Site
Gonzales, Texas, 78629, United States
GSK Investigational Site
Houston, Texas, 77030, United States
GSK Investigational Site
Houston, Texas, 77034, United States
GSK Investigational Site
Houston, Texas, 77043, United States
GSK Investigational Site
Katy, Texas, 77450, United States
GSK Investigational Site
Kerrville, Texas, 78028, United States
GSK Investigational Site
Kingwood, Texas, 77339, United States
GSK Investigational Site
Lewisville, Texas, 75067, United States
GSK Investigational Site
Longview, Texas, 75605, United States
GSK Investigational Site
Plano, Texas, 75093, United States
GSK Investigational Site
San Antonio, Texas, 78215, United States
GSK Investigational Site
San Antonio, Texas, 78229, United States
GSK Investigational Site
Sealy, Texas, 77474, United States
GSK Investigational Site
Sugar Land, Texas, 77479, United States
GSK Investigational Site
Tomball, Texas, 77375, United States
GSK Investigational Site
Abingdon, Virginia, 24210, United States
GSK Investigational Site
Hampton, Virginia, 23666, United States
GSK Investigational Site
Lynchburg, Virginia, 24501, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Richmond, Virginia, 23229, United States
GSK Investigational Site
Richmond, Virginia, 23249, United States
GSK Investigational Site
Virginia Beach, Virginia, 23454, United States
GSK Investigational Site
Bellingham, Washington, 98225, United States
GSK Investigational Site
Everett, Washington, 98208, United States
GSK Investigational Site
Renton, Washington, 98055, United States
GSK Investigational Site
Renton, Washington, 98057, United States
GSK Investigational Site
Seattle, Washington, 98122, United States
GSK Investigational Site
Spokane Valley, Washington, 99216, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Bahía Blanca, Buenos Aires, B8000AAK, Argentina
GSK Investigational Site
CABA, Buenos Aires, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1028AAP, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1414AIF, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425AGC, Argentina
GSK Investigational Site
Florida, Buenos Aires, 1602, Argentina
GSK Investigational Site
La Plata, Buenos Aires, 1900, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, 7600, Argentina
GSK Investigational Site
Mar del Plata, Buenos Aires, B7600FZN, Argentina
GSK Investigational Site
Nueve de Julio, Buenos Aires, B6500BWQ, Argentina
GSK Investigational Site
Paraná, Buenos Aires, E3100BHK, Argentina
GSK Investigational Site
Vicente López, Buenos Aires, B1602DOH, Argentina
GSK Investigational Site
Córdoba, Córdoba Province, X5003DCE, Argentina
GSK Investigational Site
Concepción del Uruguay, Entre Ríos Province, 3260, Argentina
GSK Investigational Site
San Rafael, Mendoza Province, 5600, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, 2000, Argentina
GSK Investigational Site
Rosario, Santa Fe Province, S2002OJN, Argentina
GSK Investigational Site
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
GSK Investigational Site
Berazategui, 1886, Argentina
GSK Investigational Site
Berazategui, Buenos Aires, B1884AAC, Argentina
GSK Investigational Site
Buenos Aires, C1120AAC, Argentina
GSK Investigational Site
Buenos Aires, C1121ABE, Argentina
GSK Investigational Site
Buenos Aires, C1128AAF, Argentina
GSK Investigational Site
Buenos Aires, C1424BSF, Argentina
GSK Investigational Site
Buenos Aires, C1425BEN, Argentina
GSK Investigational Site
Buenos Aires, C1426ABP, Argentina
GSK Investigational Site
Capital Federal, C1440BRR, Argentina
GSK Investigational Site
Ciudad Autonoma de Buenis Aires, C1015ABR, Argentina
GSK Investigational Site
Coronel Suárez, 7540, Argentina
GSK Investigational Site
Córdoba, 5000, Argentina
GSK Investigational Site
Mendoza, 5500, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
Monte Grande, 1842, Argentina
GSK Investigational Site
Salta, A4400ERH, Argentina
GSK Investigational Site
San Miguel de Tucumán, 4000, Argentina
GSK Investigational Site
Santa Fe, 3000, Argentina
GSK Investigational Site
Santa Rosa, 6300, Argentina
GSK Investigational Site
Concord, New South Wales, 2139, Australia
GSK Investigational Site
Gosford, New South Wales, 2250, Australia
GSK Investigational Site
Maroubra, New South Wales, 2035, Australia
GSK Investigational Site
Westmead, New South Wales, 2145, Australia
GSK Investigational Site
Cairns, Queensland, 4870, Australia
GSK Investigational Site
Carina Heights, Queensland, 4152, Australia
GSK Investigational Site
Adelaide, South Australia, 5000, Australia
GSK Investigational Site
Daw Park, South Australia, 5041, Australia
GSK Investigational Site
Clayton, Victoria, 3168, Australia
GSK Investigational Site
Footscray, Victoria, 3011, Australia
GSK Investigational Site
Frankston, Victoria, 3199, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Hamilton, Victoria, 3300, Australia
GSK Investigational Site
Murdoch, Western Australia, 6964, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Liverpool, 2107, Australia
GSK Investigational Site
Feldbach, 8330, Austria
GSK Investigational Site
Feldkirch, 6800, Austria
GSK Investigational Site
Grieskirchen, A-4710, Austria
GSK Investigational Site
Thalheim bei Wels, 4600, Austria
GSK Investigational Site
Vienna, A-1030, Austria
GSK Investigational Site
Antwerp, 2060, Belgium
GSK Investigational Site
Bruges, 8000, Belgium
GSK Investigational Site
Brussels, 1200, Belgium
GSK Investigational Site
Erpent, 5101, Belgium
GSK Investigational Site
Genk, 3600, Belgium
GSK Investigational Site
Ghent, 9000, Belgium
GSK Investigational Site
Gilly, 6060, Belgium
GSK Investigational Site
Hasselt, 3500, Belgium
GSK Investigational Site
Liège, 4000, Belgium
GSK Investigational Site
Malmedy, 4960, Belgium
GSK Investigational Site
Mechelen, 2800, Belgium
GSK Investigational Site
Montigny-le-Tilleul, 6110, Belgium
GSK Investigational Site
Ostend, 8400, Belgium
GSK Investigational Site
Roeselaere, 8800, Belgium
GSK Investigational Site
Turnhout, 2300, Belgium
GSK Investigational Site
Recife, Pernambuco, 50920-900, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90480-000, Brazil
GSK Investigational Site
Porto Alegre, Rio Grande do Sul, 90610000, Brazil
GSK Investigational Site
Blumenau, Santa Catarina, 89030-101, Brazil
GSK Investigational Site
Florianópolis, Santa Catarina, 88040-970, Brazil
GSK Investigational Site
Rio de Janeiro, 21941-913, Brazil
GSK Investigational Site
São Paulo, 01323903, Brazil
GSK Investigational Site
São Paulo, 04023900, Brazil
GSK Investigational Site
São Paulo, 04266-010, Brazil
GSK Investigational Site
São Paulo, 05403-000, Brazil
GSK Investigational Site
Edmonton, Alberta, T6G 2G3, Canada
GSK Investigational Site
Sherwood Park, Alberta, T8H 0N2, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2H 2A6, Canada
GSK Investigational Site
Winnipeg, Manitoba, R2K 3S8, Canada
GSK Investigational Site
Moncton, New Brunswick, E1G 2K5, Canada
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Cornwall, Ontario, K6H4M4, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3A 1Y8, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Hamilton, Ontario, L8L 5G8, Canada
GSK Investigational Site
Hamilton, Ontario, L8N 3Z5, Canada
GSK Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
GSK Investigational Site
Toronto, Ontario, M3J 2C5, Canada
GSK Investigational Site
Toronto, Ontario, M4S 1Y2, Canada
GSK Investigational Site
Toronto, Ontario, M5T 3A9, Canada
GSK Investigational Site
Toronto, Ontario, M9C 4Z5, Canada
GSK Investigational Site
Toronto, Ontario, M9W 4L6, Canada
GSK Investigational Site
Windsor, Ontario, N8X 5A6, Canada
GSK Investigational Site
Gatineau, Quebec, J8Y 6S8, Canada
GSK Investigational Site
Mirabel, Quebec, J7J 2K8, Canada
GSK Investigational Site
Montreal, Quebec, H1M 1B1, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G5, Canada
GSK Investigational Site
Québec, Quebec, G3K 2P8, Canada
GSK Investigational Site
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
GSK Investigational Site
Trois-Rivières, Quebec, G8T 7A1, Canada
GSK Investigational Site
Curicó, Maule Region, 3341643, Chile
GSK Investigational Site
Talca, Maule Region, 3465584, Chile
GSK Investigational Site
Valparaíso, Región de Valparaíso, 2341131, Chile
GSK Investigational Site
Viña del Mar, Región de Valparaíso, 2520024, Chile
GSK Investigational Site
Concepción, Región Del Biobio, 4070038, Chile
GSK Investigational Site
Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500692, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7500710, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7510186, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7750495, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 7860406, Chile
GSK Investigational Site
Santiago, Región Metro de Santiago, 8360160, Chile
GSK Investigational Site
Santiago, 7500698, Chile
GSK Investigational Site
Santiago, 8380453, Chile
GSK Investigational Site
Talcahuano, 4270918, Chile
GSK Investigational Site
Viña del Mar, 2520594, Chile
GSK Investigational Site
Guangzhou, Guangdong, 510080, China
GSK Investigational Site
Guangzhou, Guangdong, 510120, China
GSK Investigational Site
Guangzhou, Guangdong, 510150, China
GSK Investigational Site
Guangzhou, Guangdong, 510180, China
GSK Investigational Site
Guangzhou, Guangdong, 510630, China
GSK Investigational Site
Zhanjiang, Guangdong, 524001, China
GSK Investigational Site
Nanning, Guangxi, 530021, China
GSK Investigational Site
Haikou, Hainan, 570311, China
GSK Investigational Site
Shijiazhuang, Hebei, 050000, China
GSK Investigational Site
Nanjing, Jiangsu, 210006, China
GSK Investigational Site
Nanjing, Jiangsu, 210008, China
GSK Investigational Site
Nanjing, Jiangsu, 210029, China
GSK Investigational Site
Nanchang, Jiangxi, 330006, China
GSK Investigational Site
Changchun, Jilin, 130041, China
GSK Investigational Site
Shenyang, Liaoning, 110004, China
GSK Investigational Site
Shenyang, Liaoning, 110015, China
GSK Investigational Site
Yinchuan, Ningxia, 750004, China
GSK Investigational Site
Jinan, Shandong, 250012, China
GSK Investigational Site
Jinan, Shandong, 250013, China
GSK Investigational Site
Qingdao, Shandong, 266071, China
GSK Investigational Site
Taiyuan, Shanxi, 030001, China
GSK Investigational Site
Xian, Shanxi, 710032, China
GSK Investigational Site
Chengdu, Sichuan, 610041, China
GSK Investigational Site
Hangzhou, Zhejiang, China
GSK Investigational Site
Beijing, 100020, China
GSK Investigational Site
Beijing, 100029, China
GSK Investigational Site
Beijing, 100034, China
GSK Investigational Site
Beijing, 100050, China
GSK Investigational Site
Beijing, 100191, China
GSK Investigational Site
Changsha, 410013, China
GSK Investigational Site
Chongqing, 400037, China
GSK Investigational Site
Chongqing, 400038, China
GSK Investigational Site
Chongqing, China
GSK Investigational Site
Fuzhou, 350025, China
GSK Investigational Site
Guangzhou, 510080, China
GSK Investigational Site
Nanchang, 330006, China
GSK Investigational Site
Shanghai, 200025, China
GSK Investigational Site
Shanghai, 200433, China
GSK Investigational Site
Tianjin, 300052, China
GSK Investigational Site
Wuxi, 214023, China
GSK Investigational Site
Barranquilla, Colombia
GSK Investigational Site
Bogotá, 80CO, Colombia
GSK Investigational Site
Bogotá, Colombia
GSK Investigational Site
Medellín, Colombia
GSK Investigational Site
Benešov, 256 30, Czechia
GSK Investigational Site
Brandýs nad Labem, 250 01, Czechia
GSK Investigational Site
Cvikov, 471 54, Czechia
GSK Investigational Site
Holešov, 769 01, Czechia
GSK Investigational Site
Hradec Králové, 500 05, Czechia
GSK Investigational Site
Jaroměř, 551 01, Czechia
GSK Investigational Site
Olomouc, 772 00, Czechia
GSK Investigational Site
Olomouc, 775 20, Czechia
GSK Investigational Site
Ostrava - Poruba, 70868, Czechia
GSK Investigational Site
Pilsen, 301 00, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Prague, 182 00, Czechia
GSK Investigational Site
Tábor, 390 19, Czechia
GSK Investigational Site
Teplice, 415 10, Czechia
GSK Investigational Site
Třebíč, 674 01, Czechia
GSK Investigational Site
Aalborg, 9100, Denmark
GSK Investigational Site
Aarhus C, 8000, Denmark
GSK Investigational Site
Hellerup, 2900, Denmark
GSK Investigational Site
Hvidovre, 2650, Denmark
GSK Investigational Site
Kolding, DK-6000, Denmark
GSK Investigational Site
Odense C, 5000, Denmark
GSK Investigational Site
Roskilde, 4000, Denmark
GSK Investigational Site
Sønderborg, 6400, Denmark
GSK Investigational Site
Espoo, 02740, Finland
GSK Investigational Site
Helsinki, 00290, Finland
GSK Investigational Site
Jyväskylä, 40100, Finland
GSK Investigational Site
Lohja, 08200, Finland
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Turku, 20100, Finland
GSK Investigational Site
Turku, 20520, Finland
GSK Investigational Site
Bayonne, 64109, France
GSK Investigational Site
Brest, 29609, France
GSK Investigational Site
Briis-sous-Forge, 91640, France
GSK Investigational Site
Grenoble, 38043, France
GSK Investigational Site
Le Mans, 72000, France
GSK Investigational Site
Lyon, 69317, France
GSK Investigational Site
Marseille, 13331, France
GSK Investigational Site
Montauban, 82017, France
GSK Investigational Site
Montpellier, 34295, France
GSK Investigational Site
Nîmes, 30900, France
GSK Investigational Site
Orléans, 45067, France
GSK Investigational Site
Paris, 75014, France
GSK Investigational Site
Perpignan, 66000, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Pringy, 74374, France
GSK Investigational Site
Rennes, 35033, France
GSK Investigational Site
Strasbourg, 67091, France
GSK Investigational Site
Toulon, 83000, France
GSK Investigational Site
Vandœuvre-lès-Nancy, 54511, France
GSK Investigational Site
Deggingen, Baden-Wurttemberg, 73326, Germany
GSK Investigational Site
Leonberg, Baden-Wurttemberg, 71229, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68161, Germany
GSK Investigational Site
Mannheim, Baden-Wurttemberg, 68167, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70372, Germany
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70378, Germany
GSK Investigational Site
Wiesloch, Baden-Wurttemberg, 69168, Germany
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Augsburg, Bavaria, 86150, Germany
GSK Investigational Site
Bad Woerrishofen, Bavaria, 86825, Germany
GSK Investigational Site
Bamberg, Bavaria, 96049, Germany
GSK Investigational Site
Dachau, Bavaria, 85221, Germany
GSK Investigational Site
Dillingen an der Donau, Bavaria, 89407, Germany
GSK Investigational Site
Donaustauf, Bavaria, 93093, Germany
GSK Investigational Site
Garmisch-Partenirchen, Bavaria, 82467, Germany
GSK Investigational Site
Gauting, Bavaria, 82131, Germany
GSK Investigational Site
Landsberg am Lech, Bavaria, 86899, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Munich, Bavaria, 80539, Germany
GSK Investigational Site
Neu-Ulm, Bavaria, 89231, Germany
GSK Investigational Site
Nuremberg, Bavaria, 90402, Germany
GSK Investigational Site
Rosenheim, Bavaria, 83022, Germany
GSK Investigational Site
Wallerfing, Bavaria, 94574, Germany
GSK Investigational Site
Cottbus, Brandenburg, 03050, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14467, Germany
GSK Investigational Site
Potsdam, Brandenburg, 14469, Germany
GSK Investigational Site
Rathenow, Brandenburg, 14712, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Bensheim, Hesse, 64625, Germany
GSK Investigational Site
Frankenberg, Hesse, 35066, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60389, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Fulda, Hesse, 36039, Germany
GSK Investigational Site
Fuldatal, Hesse, 34233, Germany
GSK Investigational Site
Kassel, Hesse, 34121, Germany
GSK Investigational Site
Marburg, Hesse, 35037, Germany
GSK Investigational Site
Neu-Isenburg, Hesse, 63263, Germany
GSK Investigational Site
Offenbach, Hesse, 63071, Germany
GSK Investigational Site
Rodgau, Hesse, 63110, Germany
GSK Investigational Site
Rüsselsheim am Main, Hesse, 65428, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30167, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30173, Germany
GSK Investigational Site
Peine, Lower Saxony, 31224, Germany
GSK Investigational Site
Wardenburg, Lower Saxony, 26203, Germany
GSK Investigational Site
Bad Lippspringe, North Rhine-Westphalia, 33175, Germany
GSK Investigational Site
Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53119, Germany
GSK Investigational Site
Bonn, North Rhine-Westphalia, 53123, Germany
GSK Investigational Site
Cologne, North Rhine-Westphalia, 51065, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, 44263, Germany
GSK Investigational Site
Duisburg, North Rhine-Westphalia, 47057, Germany
GSK Investigational Site
Düren, North Rhine-Westphalia, 52349, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45277, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45355, Germany
GSK Investigational Site
Freudenberg, North Rhine-Westphalia, 57258, Germany
GSK Investigational Site
Gelsenkirchen, North Rhine-Westphalia, 45879, Germany
GSK Investigational Site
Gummersbach, North Rhine-Westphalia, 51643, Germany
GSK Investigational Site
Hagen, North Rhine-Westphalia, 58089, Germany
GSK Investigational Site
Kleve, North Rhine-Westphalia, 47533, Germany
GSK Investigational Site
Neuss, North Rhine-Westphalia, 41462, Germany
GSK Investigational Site
Ratingen, North Rhine-Westphalia, 40878, Germany
GSK Investigational Site
Rheine, North Rhine-Westphalia, 48431, Germany
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42699, Germany
GSK Investigational Site
Warendorf, North Rhine-Westphalia, 48231, Germany
GSK Investigational Site
Witten, North Rhine-Westphalia, 58452, Germany
GSK Investigational Site
Bernkastel-Kues, Rhineland-Palatinate, 54470, Germany
GSK Investigational Site
Koblenz, Rhineland-Palatinate, 56068, Germany
GSK Investigational Site
Mainz, Rhineland-Palatinate, 55116, Germany
GSK Investigational Site
Neuwied, Rhineland-Palatinate, 56564, Germany
GSK Investigational Site
Wissen, Rhineland-Palatinate, 57537, Germany
GSK Investigational Site
Saarbrücken, Saarland, 66111, Germany
GSK Investigational Site
Auerbach, Saxony, 08209, Germany
GSK Investigational Site
Delitzsch, Saxony, 04509, Germany
GSK Investigational Site
Leipzg, Saxony, 04109, Germany
GSK Investigational Site
Leipzig, Saxony, 04103, Germany
GSK Investigational Site
Leipzig, Saxony, 04157, Germany
GSK Investigational Site
Leipzig, Saxony, 04275, Germany
GSK Investigational Site
Leipzig, Saxony, 04357, Germany
GSK Investigational Site
Halberstadt, Saxony-Anhalt, 38820, Germany
GSK Investigational Site
Halle, Saxony-Anhalt, 06108, Germany
GSK Investigational Site
Hettstedt, Saxony-Anhalt, 06333, Germany
GSK Investigational Site
Teuchern, Saxony-Anhalt, 06682, Germany
GSK Investigational Site
Zerbst, Saxony-Anhalt, 39261, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23558, Germany
GSK Investigational Site
Reinfeld, Schleswig-Holstein, 23858, Germany
GSK Investigational Site
Schleswig, Schleswig-Holstein, 24837, Germany
GSK Investigational Site
Gera, Thuringia, 07548, Germany
GSK Investigational Site
Saalfeld, Thuringia, 07318, Germany
GSK Investigational Site
Schmölln, Thuringia, 04626, Germany
GSK Investigational Site
Berlin, 10119, Germany
GSK Investigational Site
Berlin, 10247, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10625, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10961, Germany
GSK Investigational Site
Berlin, 10969, Germany
GSK Investigational Site
Berlin, 12043, Germany
GSK Investigational Site
Berlin, 12157, Germany
GSK Investigational Site
Berlin, 12159, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Berlin, 12627, Germany
GSK Investigational Site
Berlin, 13057, Germany
GSK Investigational Site
Berlin, 13086, Germany
GSK Investigational Site
Berlin, 13156, Germany
GSK Investigational Site
Berlin, 13187, Germany
GSK Investigational Site
Berlin, 13353, Germany
GSK Investigational Site
Berlin, 13507, Germany
GSK Investigational Site
Berlin, 13581, Germany
GSK Investigational Site
Berlin, 14059, Germany
GSK Investigational Site
Deggendorf, 94469, Germany
GSK Investigational Site
Hamburg, 22291, Germany
GSK Investigational Site
Hamburg, 22299, Germany
GSK Investigational Site
Hamburg, 22763, Germany
GSK Investigational Site
Witten, 58452, Germany
GSK Investigational Site
Kwun Tong, Hong Kong
GSK Investigational Site
Lai Chi Kok, Hong Kong
GSK Investigational Site
Pokfulam, Hong Kong
GSK Investigational Site
Shatin, Hong Kong
GSK Investigational Site
Tuenmen, Hong Kong
GSK Investigational Site
Afula, 18101, Israel
GSK Investigational Site
Ashkelon, 78278, Israel
GSK Investigational Site
Haifa, 34362, Israel
GSK Investigational Site
Holon, 58100, Israel
GSK Investigational Site
Jerusalem, 91031, Israel
GSK Investigational Site
Jerusalem, 91120, Israel
GSK Investigational Site
Kfar Saba, 44281, Israel
GSK Investigational Site
Petah Tikva, 49100, Israel
GSK Investigational Site
Ramat Gan, 52621, Israel
GSK Investigational Site
Rehovot, 76100, Israel
GSK Investigational Site
Tel Aviv, 64239, Israel
GSK Investigational Site
Tel Aviv, 67891, Israel
GSK Investigational Site
Zrifin, 70300, Israel
GSK Investigational Site
Aichi, 455-8530, Japan
GSK Investigational Site
Aichi, 457-8510, Japan
GSK Investigational Site
Aichi, 457-8511, Japan
GSK Investigational Site
Aichi, 460-0001, Japan
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Aichi, 471-8513, Japan
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Aichi, 485-0041, Japan
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Aichi, 489-8642, Japan
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Chiba, 278-0004, Japan
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Chiba, 296-8602, Japan
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Ehime, 791-0281, Japan
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Fukuoka, 802-0052, Japan
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Fukuoka, 802-0083, Japan
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Fukuoka, 811-1394, Japan
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Fukuoka, 816-0813, Japan
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Fukuoka, 820-8505, Japan
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Fukuoka, 832-0059, Japan
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Gifu, 500-8717, Japan
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Gifu, 506-8550, Japan
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Gifu, 509-6134, Japan
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Gunma, 372-0831, Japan
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Gunma, 373-0807, Japan
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Hiroshima, 722-8503, Japan
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Hiroshima, 734-8530, Japan
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Hiroshima, 735-8585, Japan
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Hokkaido, 001-0901, Japan
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Hokkaido, 053-8506, Japan
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Hokkaido, 060-0033, Japan
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Hokkaido, 062-8618, Japan
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Hokkaido, 063-0005, Japan
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Hokkaido, 064-0801, Japan
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Hokkaido, 064-0915, Japan
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Hokkaido, 070-8644, Japan
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Hokkaido, 071-8132, Japan
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Hokkaido, 078-8211, Japan
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Hokkaido, 080-0805, Japan
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Hyōgo, 650-0047, Japan
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Hyōgo, 651-0072, Japan
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Hyōgo, 653-0013, Japan
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Hyōgo, 664-8540, Japan
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Hyōgo, 670-0849, Japan
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Hyōgo, 672-8064, Japan
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Hyōgo, 674-0063, Japan
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Hyōgo, 675-8611, Japan
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Ibaraki, 302-0022, Japan
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Ibaraki, 310-0015, Japan
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Ibaraki, 311-3193, Japan
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Ibaraki, 317-0077, Japan
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Ibaraki, 319-1113, Japan
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Ishikawa, 920-8530, Japan
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Ishikawa, 920-8610, Japan
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Ishikawa, 921-8105, Japan
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Ishikawa, 923-8560, Japan
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Kagawa, 760-0018, Japan
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Kagawa, 760-8538, Japan
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Kagawa, 761-8073, Japan
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Kagawa, 762-8550, Japan
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Kanagawa, 210-0852, Japan
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Kanagawa, 232-0024, Japan
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Kanagawa, 232-0066, Japan
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Kanagawa, 239-0821, Japan
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Kanagawa, 252-5188, Japan
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Kanagawa, 254-8502, Japan
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Kochi, 780-8077, Japan
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Kumamoto, 861-1196, Japan
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Kyoto, 601-1495, Japan
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Kyoto, 607-8062, Japan
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Kyoto, 615-8087, Japan
GSK Investigational Site
Mie, 510-8567, Japan
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Mie, 515-8544, Japan
GSK Investigational Site
Miyagi, 984-8560, Japan
GSK Investigational Site
Miyagi, 985-8506, Japan
GSK Investigational Site
Miyagi, 986-8522, Japan
GSK Investigational Site
Miyagi, 989-1253, Japan
GSK Investigational Site
Nagano, 392-8510, Japan
GSK Investigational Site
Niigata, 940-0856, Japan
GSK Investigational Site
Numakunai, 020-0055, Japan
GSK Investigational Site
Okayama, 701-0304, Japan
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Okayama, 702-8055, Japan
GSK Investigational Site
Okayama, 711-0921, Japan
GSK Investigational Site
Okinawa, 901-2121, Japan
GSK Investigational Site
Okinawa, 901-2132, Japan
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Okinawa, 901-2393, Japan
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Okinawa, 904-2143, Japan
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Okinawa, 904-2293, Japan
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Osaka, 530-0001, Japan
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Osaka, 533-0024, Japan
GSK Investigational Site
Osaka, 559-0012, Japan
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Osaka, 564-0013, Japan
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Osaka, 576-0016, Japan
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Osaka, 576-0041, Japan
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Osaka, 591-8037, Japan
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Osaka, 591-8555, Japan
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Osaka, 596-8501, Japan
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Ōita, 870-0921, Japan
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Saitama, 349-1105, Japan
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Shizuoka, 420-8527, Japan
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Shizuoka, 430-8525, Japan
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Tochigi, 320-0065, Japan
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Tokyo, 103-0027, Japan
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Tokyo, 103-0028, Japan
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Tokyo, 104-8560, Japan
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Tokyo, 120-0033, Japan
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Tokyo, 134-0083, Japan
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Tokyo, 158-8531, Japan
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Tokyo, 194-0023, Japan
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Tokyo, 198-0042, Japan
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Tokyo, 204-8585, Japan
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Toyama, 937-0042, Japan
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Toyama, 938-8502, Japan
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Wakayama, 640-8558, Japan
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Yamagata, 990-8533, Japan
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Yamanashi, 400-0031, Japan
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Yamanashi, 400-8506, Japan
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's-Hertogenbosch, 5223 GZ, Netherlands
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Alkmaar, 1815 JD, Netherlands
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Almelo, 7606 SB, Netherlands
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Almelo, 7609 PP, Netherlands
GSK Investigational Site
Assen, 9401 RK, Netherlands
GSK Investigational Site
Beek, 6191 JW, Netherlands
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Breda, 4818 CK, Netherlands
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Dordrecht, 3318 AT, Netherlands
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Eindhoven, 5623 EJ, Netherlands
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Enschede, 7513 ER, Netherlands
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Groningen, 9728 NT, Netherlands
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Harderwijk, 3844 DG, Netherlands
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Helmond, 5707 HA, Netherlands
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Hoofddorp, 2134 TM, Netherlands
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Hoorn, 1624 NP, Netherlands
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Kloosterhaar, 7694 AC, Netherlands
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Leeuwarden, 8934 AD, Netherlands
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Nieuwegein, 3435 CM, Netherlands
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Rotterdam, 3083 AN, Netherlands
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Sneek, 8601 ZR, Netherlands
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Spijkenisse, 3207 NB, Netherlands
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Veldhoven, 5504 DB, Netherlands
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Zutphen, 7207 AE, Netherlands
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Zwolle, 8025 AB, Netherlands
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Auckland, 1051, New Zealand
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Dunedin, 9012, New Zealand
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Newtown, Wellington, 6021, New Zealand
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Tauranga, 3112, New Zealand
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Wellington, 6021, New Zealand
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Bodø, 8005, Norway
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Fredrikstad, 1606, Norway
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Hakadal, 1487, Norway
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Kløfta, 2040, Norway
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Levanger, 7600, Norway
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Oslo, 0953, Norway
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Stavanger, 4005, Norway
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Stavanger, 4011, Norway
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Trondheim, 7027, Norway
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Pueblo Libre, Lima region, Lima 21, Peru
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San Martín de Porres, Lima region, Lima 31, Peru
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San Miguel, Lima region, Lima 32, Peru
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Lima, L 33, Peru
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Lima, L41, Peru
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Lima, Lima 14, Peru
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Lima, Lima 18, Peru
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Lima, Lima 1, Peru
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Lima, Lima 27, Peru
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Lima, Lima 32, Peru
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Lima, Lima 41, Peru
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Caloocan, 1400, Philippines
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Iloilo City, 5000, Philippines
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Jaro, Iloilo City, 5000, Philippines
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Pasig, 1605, Philippines
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Quezon City, 1100, Philippines
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Bialystok, 15-351, Poland
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Ostrowiec Świętokrzyski, 27-400, Poland
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Sopot, 81-741, Poland
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Szczecin, 71-124, Poland
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Tarnów, 33-100, Poland
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Zgierz, 95-100, Poland
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Guaynabo, 00968, Puerto Rico
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Mayagüez, 00680, Puerto Rico
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Ponce, 00716, Puerto Rico
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San Juan, 00921, Puerto Rico
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San Juan, 00927, Puerto Rico
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Brasov, 500283, Romania
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Brăila, 810003, Romania
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Bucharest, 020125, Romania
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Comuna Alexandru Cel Bun, 617507, Romania
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Constanța, 900002, Romania
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Ploieşti, 100184, Romania
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Ploieşti, 100379, Romania
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Râmnicu Vâlcea, 240564, Romania
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Barnaul, 656038, Russia
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Belgorod, 308007, Russia
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Blagoveshchensk, 675000, Russia
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Chita, 672000, Russia
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Chita, 672090, Russia
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Ivanovo, 153005, Russia
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Kazan', 420012, Russia
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Kazan', 420015, Russia
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Krasnodar, 350012, Russia
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Krasnoyarsk, 660022, Russia
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Moscow, 119002, Russia
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Moscow, 127018, Russia
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Novosibirsk, 630087, Russia
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Petrozavodsk, 185019, Russia
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Pyatigorsk, 357538, Russia
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Ryazan, 390005, Russia
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Ryazan, 390039, Russia
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Saint Petersburg, 194354, Russia
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Saint Petersburg, 194356, Russia
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Saint Petersburg, 198216, Russia
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Saratov, 410053, Russia
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Stavropol, 355017, Russia
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Tomsk, 634009, Russia
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Tomsk, 634050, Russia
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Ulan-Ude, 670031, Russia
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Ulyanovsk, 432063, Russia
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Vladivostok, 690002, Russia
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Vladivostok, 690950, Russia
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Voronezh, 394066, Russia
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Vsevolozhsk, Leningrad Region, 188640, Russia
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Yaroslavl, 150003, Russia
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Yaroslavl, 150010, Russia
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Yekaterinburg, 620109, Russia
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Singapore, 117599, Singapore
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Singapore, 169856, Singapore
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Singapore, 529889, Singapore
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Singapore, 609606, Singapore
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Benoni, Gauteng, 1501, South Africa
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Boksburg, Gauteng, 1459, South Africa
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Pretoria, Gauteng, 0183, South Africa
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Val de Grace, Pretoria, Gauteng, 0184, South Africa
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Bellville, 7530, South Africa
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Bloemfontein, 9301, South Africa
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Cape Town, 7572, South Africa
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CapeTown, 7764, South Africa
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Durban, 4001, South Africa
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Durban, 4091, South Africa
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eManzimtoti, 4126, South Africa
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Gatesville, 7764, South Africa
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Johannesburg, 2113, South Africa
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Korsten, 6014, South Africa
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Mowbray, 7700, South Africa
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Paarl, 7646, South Africa
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Panorama, 7500, South Africa
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Tygerberg, 7505, South Africa
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Bucheon City, Gyenggi-do, 420-767, South Korea
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Cheongju-si, Chungcheongbuk-do, 361-763, South Korea
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Gyeonggi-do, 410-719, South Korea
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Gyeonggi-do, 431-796, South Korea
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Gyeonggi-do, 463-707, South Korea
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Incheon, 403-720, South Korea
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Incheon, 405-760, South Korea
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Jeonju, 561-712, South Korea
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Kangwon-do, 220-701, South Korea
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Seoul, 110-744, South Korea
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Seoul, 130-709, South Korea
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Seoul, 130-872, South Korea
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Seoul, 134-791, South Korea
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Seoul, 134-814, South Korea
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Seoul, 136-705, South Korea
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Seoul, 150-713, South Korea
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Seoul, 156-707, South Korea
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Marbella - Málaga, Andalusia, 29603, Spain
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Torrelavega, Cantabria, 39300, Spain
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Badalona, Catalonia, 08916, Spain
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(Badalona) Barcelona, 08911, Spain
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(Barakaldo) Vizcaya, 48903, Spain
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A Coruña, 15006, Spain
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A Coruña, 15011, Spain
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Alicante, 03004, Spain
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Alzira/Valencia, 46600, Spain
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Barcelona, 08003, Spain
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Barcelona, 08006, Spain
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Barcelona, 08017, Spain
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Barcelona, 08023, Spain
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Barcelona, 08028, Spain
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Barcelona, 08035, Spain
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Barcelona, 08036, Spain
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Barcelona, 08041, Spain
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Basurto/Bilbao, 48013, Spain
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Burgos, 09006, Spain
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Cáceres, 10003, Spain
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Centelles (Barcelona), 08540, Spain
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Coslada, 28822, Spain
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Girona, 17005, Spain
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Girona, 17007, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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La Roca Del Valles (Barcelona), 08430, Spain
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Lleida, 25198, Spain
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Madrid, 28006, Spain
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Madrid, 28040, Spain
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Mataró, 08303, Spain
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Málaga, 29010, Spain
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Pozuelo de Alarcón/Madrid, 28223, Spain
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Sabadell (Barcelona), 08208, Spain
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Sagunto/Valencia, 46520, Spain
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Salamanca, 37007, Spain
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San Sebastián de los Reyes, 28702, Spain
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Sant Joan d'Alacant, 3550, Spain
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Santander, 39008, Spain
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Seville, 41013, Spain
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Tarragona, 43002, Spain
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Valencia, 46015, Spain
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Valencia, 46017, Spain
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Valladolid, 47012, Spain
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Vizcaya, 48902, Spain
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Zaragoza, 50009, Spain
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Borås, SE-506 30, Sweden
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Gothenburg, SE-413 45, Sweden
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Gothenburg, SE-413 90, Sweden
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Höllviken, SE-236 32, Sweden
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Linköping, SE-587 58, Sweden
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Luleå, SE-971 89, Sweden
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Örebro, SE-703 62, Sweden
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Östersund, SE-831 83, Sweden
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Stockholm, SE-111 57, Sweden
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Uppsala, SE-752 37, Sweden
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Bangkok, 10330, Thailand
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Bangkok, 10600, Thailand
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Chiang Mai, 50200, Thailand
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Khon Kaen, 40002, Thailand
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Muang, 11000, Thailand
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Nakhon Ratchasima, 30000, Thailand
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Nan, 55000, Thailand
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Songkhla, 90110, Thailand
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Ankara, 06100, Turkey (Türkiye)
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Istanbul, 34020, Turkey (Türkiye)
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Istanbul, 34844, Turkey (Türkiye)
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Izmir, 35100, Turkey (Türkiye)
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Mersin, 33343, Turkey (Türkiye)
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Kharkiv, 61002, Ukraine
GSK Investigational Site
Kharkiv, 61124, Ukraine
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Kiev, 03680, Ukraine
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Kyiv, 02232, Ukraine
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Kyiv, 03049, Ukraine
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Kyiv, 03680, Ukraine
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Mykolayiv, 54003, Ukraine
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Odesa, 65025, Ukraine
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Sumy, 40022, Ukraine
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Vinnytsia, 21000, Ukraine
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Exeter, Devon, EX2 5DW, United Kingdom
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Wishaw, Lanarkshire, ML2 0DP, United Kingdom
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Blackpool, Lancashire, FY3 7EN, United Kingdom
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Northwood, Middlesex, HA6 2RN, United Kingdom
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High Heaton, Newcastle Upon Tyne, Tyne & Wear, NE7 7DN, United Kingdom
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Bradford-on-Avon, Wiltshire, BA15 1DQ, United Kingdom
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Bradford, BD9 6RJ, United Kingdom
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Cambridge, CB2 0QQ, United Kingdom
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Chester, CH2 1UL, United Kingdom
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Crawley, RH10 7DX, United Kingdom
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Crownhill, Plymouth, PL5 3JB, United Kingdom
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Dundee, Scotland, DD1 9SY, United Kingdom
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Stockton-on-Tees, TS19 8PE, United Kingdom
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Trowbridge, BA14 9AR, United Kingdom
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Hà Nội, 10000, Vietnam
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Related Publications (25)
Risebrough NA, Mursleen S, Ndirangu K, Shah D, Martin A, Schroeder M, Ismaila AS. The long-term clinical and economic benefits of treating advanced COPD patients with single-inhaler triple therapy in Quebec, Canada - The IMPACT trial. Respir Med. 2024 Sep;231:107694. doi: 10.1016/j.rmed.2024.107694. Epub 2024 Jun 4.
PMID: 38844004DERIVEDAggarwal B, Jones P, Casas A, Gomes M, Juthong S, Litewka D, Ong-Dela Cruz B, Ramirez-Venegas A, Sayiner A, van Hasselt J, Compton C, Tombs L, Weng S, Levy G. Association between Increased Risk of Pneumonia with ICS in COPD: A Continuous Variable Analysis of Patient Factors from the IMPACT Study. Pulm Ther. 2024 Jun;10(2):183-192. doi: 10.1007/s41030-024-00255-1. Epub 2024 Mar 6.
PMID: 38446336DERIVEDVerstraete K, Gyselinck I, Huts H, Das N, Topalovic M, De Vos M, Janssens W. Estimating individual treatment effects on COPD exacerbations by causal machine learning on randomised controlled trials. Thorax. 2023 Oct;78(10):983-989. doi: 10.1136/thorax-2022-219382. Epub 2023 Apr 3.
PMID: 37012070DERIVEDBardsley S, Criner GJ, Halpin DMG, Han MK, Hanania NA, Hill D, Lange P, Lipson DA, Martinez FJ, Midwinter D, Siler TM, Singh D, Wise RA, van Zyl-Smit RN, Berkman N. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus dual therapy in current and former smokers with COPD: IMPACT trial post hoc analysis. Respir Med. 2022 Dec;205:107040. doi: 10.1016/j.rmed.2022.107040. Epub 2022 Nov 11.
PMID: 36470149DERIVEDDransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14.
PMID: 36102236DERIVEDThompson PJ, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lipson DA, Maghzal GJ, Martinez FJ, Midwinter D, Singh D, Tombs L, Wise RA. Effect of chronic mucus hypersecretion on treatment responses to inhaled therapies in patients with chronic obstructive pulmonary disease: Post hoc analysis of the IMPACT trial. Respirology. 2022 Dec;27(12):1034-1044. doi: 10.1111/resp.14339. Epub 2022 Aug 15.
PMID: 35970518DERIVEDThomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259.
PMID: 34972260DERIVEDBafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3):2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep. No abstract available.
PMID: 34385263DERIVEDSingh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.
PMID: 33910578DERIVEDHalpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.
PMID: 33201438DERIVEDBourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta Maria-Tome JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1):76-90. doi: 10.15326/jcopdf.2020.0158.
PMID: 33156982DERIVEDZheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.
PMID: 33124900DERIVEDMarin JM, Mateos L, Roldan J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.
PMID: 33121372DERIVEDHanania NA, Mannino DM, Criner GJ, Dransfield MT, Han MK, Jones CE, Kilbride S, Lomas DA, Martin N, Martinez FJ, Singh D, Wise RA, Halpin DMG, Lima R, Lipson DA. Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial. Chest. 2021 Mar;159(3):985-995. doi: 10.1016/j.chest.2020.09.253. Epub 2020 Oct 5.
PMID: 33031829DERIVEDTabberer M, Jones CE, Kilbride S, Halpin DMG, Lomas DA, Pascoe S, Singh D, Wise RA, Criner GJ, Lange P, Dransfield MT, Han MK, Martinez FJ, Kaisermann MC, Lipson DA. Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study. Adv Ther. 2020 Sep;37(9):3775-3790. doi: 10.1007/s12325-020-01409-8. Epub 2020 Jul 9.
PMID: 32647911DERIVEDHan MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Wise RA, Singh D, Martinez FJ. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1237-1243. doi: 10.1164/rccm.201912-2478OC.
PMID: 32584168DERIVEDDay NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respir Res. 2020 Jun 5;21(1):139. doi: 10.1186/s12931-020-01398-w.
PMID: 32503599DERIVEDBogart MR, Hopson SD, Shih HC, Stanford RH, Coutinho AD. COPD exacerbation costs in the IMPACT study: a within-trial analysis. Am J Manag Care. 2020 May 1;26(5):e150-e154. doi: 10.37765/ajmc.2020.43157.
PMID: 32436683DERIVEDHalpin DMG, Dransfield MT, Han MK, Jones CE, Kilbride S, Lange P, Lipson DA, Lomas DA, Martinez FJ, Pascoe S, Singh D, Wise R, Criner GJ. The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 2020 May 21;55(5):1901921. doi: 10.1183/13993003.01921-2019. Print 2020 May.
PMID: 32299860DERIVEDLipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.
PMID: 32162970DERIVEDIsmaila AS, Risebrough N, Schroeder M, Shah D, Martin A, Goodall EC, Ndirangu K, Criner G, Dransfield M, Halpin DM, Han MK, Lomas DA. Cost-Effectiveness Of Once-Daily Single-Inhaler Triple Therapy In COPD: The IMPACT Trial. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2681-2695. doi: 10.2147/COPD.S216072. eCollection 2019.
PMID: 31819401DERIVEDMehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.
PMID: 31321713DERIVEDPascoe S, Barnes N, Brusselle G, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Lange P, Lettis S, Lipson DA, Lomas DA, Martinez FJ, Papi A, Roche N, van der Valk RJP, Wise R, Singh D. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019 Sep;7(9):745-756. doi: 10.1016/S2213-2600(19)30190-0. Epub 2019 Jul 4.
PMID: 31281061DERIVEDLipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.
PMID: 29668352DERIVEDPascoe SJ, Lipson DA, Locantore N, Barnacle H, Brealey N, Mohindra R, Dransfield MT, Pavord I, Barnes N. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. Eur Respir J. 2016 Aug;48(2):320-30. doi: 10.1183/13993003.02165-2015. Epub 2016 Jul 13.
PMID: 27418551DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2014
First Posted
June 16, 2014
Study Start
June 30, 2014
Primary Completion
July 17, 2017
Study Completion
July 17, 2017
Last Updated
October 10, 2018
Results First Posted
October 10, 2018
Record last verified: 2018-08