A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
HZC102871: A 52-week Efficacy and Safety Study to Compare the Effect of Three Dosage Strengths of Fluticasone Furoate/GW642444 Inhalation Powder With GW642444 on the Annual Rate of Exacerbations in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
1,626
15 countries
188
Brief Summary
The Purpose of this study is to assess the efficacy and safety of three strengths of the FF/GW642444 Inhalation Powder in subject with Chronic Obstructive Pulmonary Disease (COPD)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2009
188 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 25, 2009
CompletedFirst Submitted
Initial submission to the registry
November 5, 2009
CompletedFirst Posted
Study publicly available on registry
November 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2011
CompletedResults Posted
Study results publicly available
August 19, 2013
CompletedNovember 9, 2017
October 1, 2017
2 years
November 5, 2009
May 30, 2013
October 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annual Rate of Moderate and Severe COPD Exacerbations Expressed as Least Square Mean
The annual rate of moderate and severe chronic obstructive pulmonary disease (COPD) exacerbations during the treatment (trt) period (per participant \[par.\] per year) was assessed. An exacerbation of COPD, is defined as the worsening of two or more major symptoms (dyspnea, sputum volume, sputum purulence \[color\]) for at least two consecutive days; or the worsening of any one major symptom together with any one of the minor symptoms (sore throat, cold, fever without other cause, increased cough, increased wheeze) for at least two consecutive days. The COPD exacerbation was categorized as mild, moderate and severe by the investigator. Mild: worsening symptoms of COPD that were self-managed by the par. without the use of oral corticosteroids or antibiotics; Moderate: worsening symptoms of COPD that required treatment with oral corticosteroids and/or antibiotics; Severe: worsening symptoms of COPD that required treatment with in-patient hospitalization.
From the start of the double blinded study medication until Visit 11 (Week 52)/Early Withdrawal
Secondary Outcomes (3)
Time to First Occurrence of Moderate or Severe COPD Exacerbation
From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Annual Rate of Exacerbations Requiring Systemic/Oral Corticosteroids Expressed as Least Square Mean
From the start of the double blind study medication until Visit 11 (Week 52)/Early Withdrawal
Change From Baseline in Trough FEV1 at Week 52 (Visit 11)
Baseline to Visit 11 (Week 52)/Early Withdrawal
Study Arms (4)
FF/GW642444 Inhalation Powder 100/25 mcg QD
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
FF/GW642444 Inhalation Powder 200/25 mcg QD
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
FF/GW642444 Inhalation Powder 50mcg/25mcg QD
EXPERIMENTALInhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
GW642444 25mcg QD
EXPERIMENTALLong Acting Beta Agonist(LABA)
Interventions
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) delivered within one dry powder inhaler (DPI) device for COPD
Long Acting Beta Agonist(LABA) Inhalation Powder via DPI
Eligibility Criteria
You may qualify if:
- Type of subject: outpatient
- Informed consent: Subjects must give their signed and dated written informed consent to participate.
- 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, history of vasomotor symptoms. However in questionable cases, a blood sample with FSH \> 40MIU/ml and estradiol \<40pg/ml (\<140 pmol/L) is confirmatory. 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 follow-up contact):
- Complete abstinence from intercourse from screening until the Follow-Up Phone Contact; or
- Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
- Implants of levonorgestral inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
- Injectable progestogen administered for at least 1 month prior to study medication administration and administered until the Follow-Up Phone Contact; or
- Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
- Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
- An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
- Estrogenic vaginal ring; or
- Percutaneous contraceptive patches
- Age: ≥40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society \[Celli, 2004\]: COPD is a preventable and treatable disease characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.
- +5 more criteria
You may not qualify if:
- Subjects meeting any of the following criteria must not be enrolled in the study:
- 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)
- α1-antitrypsin deficiency: Subjects with α1-antitrypsin deficiency as the underlying cause of COPD
- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, 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 (Visit 1)
- Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT scan is not available within 6 months prior to Visit 1. For sites in Germany, if a chest X-ray (or CT scan) is not available in the 6 months preceding Screening (Visit 1), the subject will not be eligible for the study.
- Risk Factors for Pneumonia: immune suppression (HIV, Lupus, etc) or other risk for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's, Myasthenia Gravis, etc).
- A moderate and severe COPD exacerbation that has not resolved at least 14 days prior to Visit 1 and at least 30 days following the last dose of oral corticosteroids (if applicable).
- Pneumonia and/or moderate and severe COPD exacerbation at Visit 1 Note: Subjects who experience a pneumonia and/or exacerbation at Screening (Visit 1) must be not continue in the study, but may be re-screened at a later time provided the pneumonia and/or COPD exacerbation has resolved prior to the re-screening visit. At the Re-screening Visit, the chest x-ray should confirm resolution of pneumonia. The Re-screening Visit must be conducted at least ≥ 14 days following the resolution date of the exacerbation and/or pneumonia and at least 30 days following the last dose of oral corticosteroids (if applicable).
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular (i.e., pacemaker), neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological 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.
- Peptic Ulcer disease: Subjects with clinically significant peptic ulcer disease that is uncontrolled.
- Hypertension: Subjects with clinically significant hypertension that is uncontrolled.
- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded if the subject has been considered cured within 5 years since diagnosis.
- Drug/food allergy: Subjects with a history of hypersensitivity to any of the study medications (e.g., beta-agonists, corticosteroid) or components of the inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a history of severe milk protein allergy that, in the opinion of the study physician, contraindicates the subject's participation will also be excluded.
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (188)
GSK Investigational Site
Birmingham, Alabama, 35235, United States
GSK Investigational Site
Birmingham, Alabama, 35294, United States
GSK Investigational Site
Jasper, Alabama, 35501, United States
GSK Investigational Site
Peoria, Arizona, 85381, United States
GSK Investigational Site
Phoenix, Arizona, 85012, United States
GSK Investigational Site
Phoenix, Arizona, 85050, United States
GSK Investigational Site
Scottsdale, Arizona, 85258, United States
GSK Investigational Site
Chula Vista, California, 91911, United States
GSK Investigational Site
Lincoln, California, 95648, United States
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Long Beach, California, 90822, United States
GSK Investigational Site
Los Angeles, California, 90048, United States
GSK Investigational Site
Mission Viejo, California, 92691, United States
GSK Investigational Site
Palo Alto, California, 94304, United States
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Poway, California, 92064, United States
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Rancho Mirage, California, 92270, United States
GSK Investigational Site
Riverside, California, 92506, United States
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Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Santa Monica, California, 90404, United States
GSK Investigational Site
Sepulveda, California, 91343, United States
GSK Investigational Site
Torrance, California, 90503, United States
GSK Investigational Site
Stamford, Connecticut, 06902, United States
GSK Investigational Site
Bay Pines, Florida, 33744, United States
GSK Investigational Site
Clearwater, Florida, 33755, United States
GSK Investigational Site
Clearwater, Florida, 33756, United States
GSK Investigational Site
Fort Myers, Florida, 33916, United States
GSK Investigational Site
Gainesville, Florida, 32608, United States
GSK Investigational Site
Miami, Florida, 33136, United States
GSK Investigational Site
Orlando, Florida, 32822, United States
GSK Investigational Site
Ormond Beach, Florida, 32174, United States
GSK Investigational Site
Tamarac, Florida, 33321, United States
GSK Investigational Site
Winter Park, Florida, 32792, United States
GSK Investigational Site
Austell, Georgia, 30106, United States
GSK Investigational Site
Decatur, Georgia, United States
GSK Investigational Site
Lawrenceville, Georgia, 30046, United States
GSK Investigational Site
Belleville, Illinois, 62220, United States
GSK Investigational Site
River Forest, Illinois, 60305, United States
GSK Investigational Site
Avon, Indiana, 46123, United States
GSK Investigational Site
Lafayette, Indiana, 47904, United States
GSK Investigational Site
Muncie, Indiana, 47304-5547, United States
GSK Investigational Site
Newburgh, Indiana, 47630, United States
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Iowa City, Iowa, 52242, United States
GSK Investigational Site
Lenexa, Kansas, 66215, United States
GSK Investigational Site
Wichita, Kansas, 67205, United States
GSK Investigational Site
Munfordville, Kentucky, 42765, United States
GSK Investigational Site
Owensboro, Kentucky, 42301, United States
GSK Investigational Site
New Orleans, Louisiana, 70115, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Columbia, Maryland, 21044, United States
GSK Investigational Site
Saint Joseph, Michigan, 49085, United States
GSK Investigational Site
Southfield, Michigan, 48034, United States
GSK Investigational Site
Minneapolis, Minnesota, 55402, United States
GSK Investigational Site
Minneapolis, Minnesota, 55407, United States
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Plymouth, Minnesota, 55441, United States
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Saint Charles, Missouri, 63301, United States
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Billings, Montana, 59102, United States
GSK Investigational Site
Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
Ocean City, New Jersey, 7712, United States
GSK Investigational Site
New York, New York, 10004, United States
GSK Investigational Site
New York, New York, 10029, United States
GSK Investigational Site
Elizabeth City, North Carolina, 27909, United States
GSK Investigational Site
Salisbury, North Carolina, 28144, United States
GSK Investigational Site
Dayton, Ohio, 45406, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73103, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
GSK Investigational Site
Tulsa, Oklahoma, 74136-8303, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Johnston, Rhode Island, 02919, United States
GSK Investigational Site
Anderson, South Carolina, 29621, United States
GSK Investigational Site
Charleston, South Carolina, 29406-7108, United States
GSK Investigational Site
Chester, South Carolina, 29706, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greenwood, South Carolina, 29646, United States
GSK Investigational Site
Greer, South Carolina, 29651, United States
GSK Investigational Site
Seneca, South Carolina, 29678, United States
GSK Investigational Site
Chattanooga, Tennessee, 37421, United States
GSK Investigational Site
New Tazewell, Tennessee, 37824-1409, United States
GSK Investigational Site
Austin, Texas, 78705, United States
GSK Investigational Site
Boerne, Texas, 78006, United States
GSK Investigational Site
Fort Worth, Texas, 76109, United States
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Kingwood, Texas, 77339, United States
GSK Investigational Site
Lake Jackson, Texas, 77566, United States
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San Antonio, Texas, 78229, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
South Burlington, Vermont, 05403, United States
GSK Investigational Site
Abingdon, Virginia, 24210, United States
GSK Investigational Site
Charlottesville, Virginia, 22911, United States
GSK Investigational Site
Fredericksburg, Virginia, 22401, United States
GSK Investigational Site
Richmond, Virginia, 23225, United States
GSK Investigational Site
Virginia Beach, Virginia, 23455, United States
GSK Investigational Site
Lakewood, Washington, 98499, United States
GSK Investigational Site
Spokane, Washington, 99204, United States
GSK Investigational Site
Tacoma, Washington, 98405, United States
GSK Investigational Site
Wenatchee, Washington, 98801, United States
GSK Investigational Site
Cipolletti, Río Negro Province, R8324EMB, 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
Buenos Aires, C1428DDE, Argentina
GSK Investigational Site
Mendoza, M5500CCG, Argentina
GSK Investigational Site
Garran, Australian Capital Territory, 2606, Australia
GSK Investigational Site
Cairns, Queensland, 4870, Australia
GSK Investigational Site
Kippa-Ring, Queensland, 4021, Australia
GSK Investigational Site
Daw Park, South Australia, 5041, Australia
GSK Investigational Site
Frankston, Victoria, 3199, Australia
GSK Investigational Site
Geelong, Victoria, 3220, Australia
GSK Investigational Site
Heidelberg, Victoria, 3084, Australia
GSK Investigational Site
Nedlands, Western Australia, 6009, Australia
GSK Investigational Site
Vancouver, British Columbia, V5Z 4E1, Canada
GSK Investigational Site
St. John's, Newfoundland and Labrador, A1E 2E2, Canada
GSK Investigational Site
Burlington, Ontario, L7N 3V2, Canada
GSK Investigational Site
Corunna, Ontario, N0N 1G0, Canada
GSK Investigational Site
Greater Sudbury, Ontario, P3E 1H5, Canada
GSK Investigational Site
Toronto, Ontario, M3H 5S4, Canada
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Toronto, Ontario, M4P 1P2, Canada
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Toronto, Ontario, M9W 4L6, Canada
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Montreal, Quebec, H2R 1V6, Canada
GSK Investigational Site
Québec, Quebec, G1V 4G5, Canada
GSK Investigational Site
Temuco, Región de La Araucania, 4800798, Chile
GSK Investigational Site
Valparaíso, Región de Valparaíso, 2341131, Chile
GSK Investigational Site
Santiago, 8380453, Chile
GSK Investigational Site
Rakvere, 44316, Estonia
GSK Investigational Site
Tallinn, 10117, Estonia
GSK Investigational Site
Tallinn, 10611, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Cassano Murge (BA), Apulia, 70020, Italy
GSK Investigational Site
Eboli (SA), Campania, 84025, Italy
GSK Investigational Site
Telese Terme (BN), Campania, 82037, Italy
GSK Investigational Site
Ferrara, Emilia-Romagna, 44100, Italy
GSK Investigational Site
Rome, Lazio, 00135, Italy
GSK Investigational Site
Rome, Lazio, 00163, Italy
GSK Investigational Site
Genoa, Liguria, 16132, Italy
GSK Investigational Site
Milan, Lombardy, 20142, Italy
GSK Investigational Site
Tradate (VA), Lombardy, 21049, Italy
GSK Investigational Site
Torrette (AN), The Marches, 60126, Italy
GSK Investigational Site
Tijuana, Baja California Norte, 22320, Mexico
GSK Investigational Site
Guadalajara, Jalisco, 44100, Mexico
GSK Investigational Site
Zapopan, Jalisco, 45040, Mexico
GSK Investigational Site
Monterrey, Nuevo León, 64060, Mexico
GSK Investigational Site
Bunnik, 3981 LB, Netherlands
GSK Investigational Site
Enschede, 7513 ER, Netherlands
GSK Investigational Site
Etten-Leur, 4872 LA, Netherlands
GSK Investigational Site
Harderwijk, 3844 DG, Netherlands
GSK Investigational Site
Heerlen, 6419 PC, Netherlands
GSK Investigational Site
Helmond, 5707 HA, Netherlands
GSK Investigational Site
Nijverdal, 7442 LS, Netherlands
GSK Investigational Site
Rotterdam, 3078 HT, Netherlands
GSK Investigational Site
Sneek, 8601 ZK, Netherlands
GSK Investigational Site
Spijkenisse, 3207 NB, Netherlands
GSK Investigational Site
Veldhoven, 5504 DB, Netherlands
GSK Investigational Site
Voerendaal, 6367 ED, Netherlands
GSK Investigational Site
Jesus Maria, Lima region, Lima 11, Peru
GSK Investigational Site
San Martín de Porres, Lima region, Lima 31, Peru
GSK Investigational Site
Lima, Lima 27, Peru
GSK Investigational Site
Lima, Lima 41, Peru
GSK Investigational Site
Dagupan, 2400, Philippines
GSK Investigational Site
Quezon City, 1100, Philippines
GSK Investigational Site
Quezon City, 1101, Philippines
GSK Investigational Site
Quezon City, 1109, Philippines
GSK Investigational Site
Cape Town, Gauteng, 7505, South Africa
GSK Investigational Site
Mueckelneck, Gauteng, 0001, South Africa
GSK Investigational Site
Boksburg North, 1459, South Africa
GSK Investigational Site
Cape Town, 8001, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Durban, 4091, South Africa
GSK Investigational Site
Groenkloof, 0181, South Africa
GSK Investigational Site
Lynnwood Manor, 0081, South Africa
GSK Investigational Site
Lyttleton, 0140, South Africa
GSK Investigational Site
Paarl, 7646, South Africa
GSK Investigational Site
Panorama, 7500, South Africa
GSK Investigational Site
Reiger Park, 1459, South Africa
GSK Investigational Site
Somerset West, 7130, South Africa
GSK Investigational Site
Witbank, 1034, South Africa
GSK Investigational Site
Gothenburg, SE-412 63, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Höllviken, SE-236 51, Sweden
GSK Investigational Site
Kil, SE-665 30, Sweden
GSK Investigational Site
Örebro, SE-703 62, Sweden
GSK Investigational Site
High Heaton, Newcastle Upon Tyne, Tyne & Wear, NE7 7DN, United Kingdom
GSK Investigational Site
Doncaster, DN9 2HY, United Kingdom
GSK Investigational Site
Liverpool, L9 7AL, United Kingdom
GSK Investigational Site
London, E7 8QP, United Kingdom
GSK Investigational Site
London, NW3 2PF, United Kingdom
GSK Investigational Site
London, SW17 0RE, United Kingdom
Related Publications (5)
Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Sanford L, Lettis S, Crim C, Calverley PM. Once-daily inhaled fluticasone furoate and vilanterol versus vilanterol only for prevention of exacerbations of COPD: two replicate double-blind, parallel-group, randomised controlled trials. Lancet Respir Med. 2013 May;1(3):210-23. doi: 10.1016/S2213-2600(13)70040-7. Epub 2013 Apr 12.
PMID: 24429127BACKGROUNDLargajolli A, Beerahee M, Yang S. Bayesian approach to investigate a two-state mixed model of COPD exacerbations. J Pharmacokinet Pharmacodyn. 2019 Aug;46(4):371-384. doi: 10.1007/s10928-019-09643-6. Epub 2019 Jun 13.
PMID: 31197640DERIVEDHinds DR, DiSantostefano RL, Le HV, Pascoe S. Identification of responders to inhaled corticosteroids in a chronic obstructive pulmonary disease population using cluster analysis. BMJ Open. 2016 Jun 1;6(6):e010099. doi: 10.1136/bmjopen-2015-010099.
PMID: 27251682DERIVEDCrim C, Dransfield MT, Bourbeau J, Jones PW, Hanania NA, Mahler DA, Vestbo J, Wachtel A, Martinez FJ, Barnhart F, Lettis S, Calverley PM. Pneumonia risk with inhaled fluticasone furoate and vilanterol compared with vilanterol alone in patients with COPD. Ann Am Thorac Soc. 2015 Jan;12(1):27-34. doi: 10.1513/AnnalsATS.201409-413OC.
PMID: 25490706DERIVEDSvedsater H, Dale P, Garrill K, Walker R, Woepse MW. Qualitative assessment of attributes and ease of use of the ELLIPTA dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med. 2013 Dec 7;13:72. doi: 10.1186/1471-2466-13-72.
PMID: 24314123DERIVED
Related Links
MeSH Terms
Conditions
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
November 5, 2009
First Posted
November 6, 2009
Study Start
September 25, 2009
Primary Completion
October 1, 2011
Study Completion
October 31, 2011
Last Updated
November 9, 2017
Results First Posted
August 19, 2013
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.