Study Evaluating the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) Compared With Vilanterol Inhalation Powder (VI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
A 12-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) 100/25 mcg Once Daily Compared With Vilanterol Inhalation Powder (VI) 25 mcg Once Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
1 other identifier
interventional
1,621
11 countries
237
Brief Summary
This is a Phase IIIa, multicenter, randomized, stratified (reversibility status), double-blind, parallel-group study to evaluate the efficacy and safety of FF/VI 100/25 micrograms (mcg) once daily (QD) compared with VI 25 mcg QD, administered in the morning via the ELLIPTA™ inhaler. The primary objective of this study is to evaluate the contribution on lung function (as measured by trough forced expiratory volume in one second \[FEV1\]) of FF 100 mcg to the FF/VI 100/25 mcg QD combination by comparison of the latter with VI 25 mcg QD and the safety of FF/VI 100/25 mcg over a 12-week treatment period in subjects with COPD. ELLIPTA™ is a registered trademark of GlaxoSmithKline.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2014
Shorter than P25 for phase_3
237 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
First Submitted
Initial submission to the registry
April 3, 2014
CompletedFirst Posted
Study publicly available on registry
April 7, 2014
CompletedStudy Start
First participant enrolled
April 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 8, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 8, 2015
CompletedResults Posted
Study results publicly available
April 13, 2016
CompletedJanuary 24, 2018
January 1, 2018
1.3 years
April 3, 2014
March 3, 2016
January 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline (BL) in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1, on Treatment Day 84
Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcefully exhaled from the lungs in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 14, 28, 56 and 84. BL was defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Treatment Day 1.Trough FEV1 was defined as the mean of the FEV1 values obtained 23 and 24 hours after previous morning's dosing. Change from BL was calculated as the average at each visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, reversibility status (stratum), BL, region, day, day by BL and day by treatment interactions.
Baseline to Day 84
Secondary Outcomes (2)
Percentage of Rescue-free 24-hour Periods Over the Entire 12-week Treatment Period
BL (Week -1), Week 1 to Week 12
Time to First On-treatment Occurrence of Moderate or Severe COPD Exacerbation
From the start of double blind study medication until visit 7 (week 12)/Early withdrawal
Study Arms (2)
Fluticasone Furoate/Vilanterol 100/25 Inhalation Powder
EXPERIMENTALInhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA)
Vilanterol 25 Inhalation Powder
EXPERIMENTALLong-acting beta2-agonist (LABA)
Interventions
100 mcg FF micronized drug blended with lactose per blister in one strip and 25 mcg VI micronized drug blended with lactose and magnesium stearate per blister in another strip, administered together by ELLIPTA™ inhaler
25 mcg of Vilanterol micronized drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister in one strip and lactose in another strip, administered together by ELLIPTA™ inhaler
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 subjects or female subjects. Female subjects must be post-menopausal or using a highly effective method for avoidance of pregnancy. The decision to include or exclude women of childbearing potential may be made at the discretion of the investigator in accordance with local practice in relation to adequate contraception.
- Age: \>=40 years of age at Screening (Visit 1)
- COPD diagnosis: Subjects with a clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society: 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 is also associated with significant systemic consequences.
- Severity of disease: Subjects with a measured post-albuterol (salbutamol) FEV1/ Forced Vital Capacity (FVC) ratio of \<=0.70 and FEV1 \>=30 to \<=70 percent of predicted normal values using Global Lung Function Initiative 2012 reference equations at Screening (Visit 1).
- Tobacco use: Subjects with a current or prior history of \>=10 pack-years of cigarette smoking at Screening (Visit 1). Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
- History of COPD exacerbation: A documented history (e.g., medical record verification) of at least one COPD exacerbation in the 12 months prior to Screening (Visit 1) that required either systemic/oral corticosteroids, antibiotics and/or hospitalization.
- Current symptoms of COPD: A Subject Diary combined symptom score (combination of breathlessness, cough, sputum, and night time awakenings requiring treatment with albuterol \[salbutamol\]) of \>=4 on at least 5 of the 7 days immediately preceding Visit 2 (Randomization)
- QTc Criteria: QTc \<450 msec or QTc \<480 msec for patients with bundle branch block.
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).
- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening (Visit 1).
- Chest X-ray (or computed tomography \[CT\] 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 1 year prior to Screening (Visit 1).
- Hospitalization: Subjects who are hospitalized due to poorly controlled COPD that has not resolved at least 4 weeks prior to Screening (Visit 1) and at least 6 weeks following the last dose of systemic corticosteroids.
- Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Screening (Visit 1): Acute worsening of COPD that is managed by subject with systemic corticosteroids or antibiotics or that requires treatment prescribed by a physician.
- Lower respiratory tract infection: Subjects with lower respiratory tract infection that required the use of antibiotics within 6 weeks prior to Screening (Visit 1).
- COPD exacerbation/lower respiratory tract infection during the Run-In Period: Subjects who experience a moderate/severe COPD exacerbation (As per definition of "COPD Exacerbations and Pneumonia" in protocol) and/or a lower respiratory tract infection (including pneumonia) during the Run-In Period.
- Abnormal, clinically significant laboratory finding: Subjects who have an abnormal clinical significant finding in any liver chemistry test at Screening (Visit 1) or upon repeat prior to randomization.
- Abnormal, clinically significant 12-lead ECG at Screening (Visit 1): Subjects who have an abnormal, clinically significant 12-Lead electrocardiogram (ECG) finding at Screening (Visit 1) or upon repeat prior to randomization.
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant and unstable disease such as cardiovascular (e.g., patients requiring implantable cardioverter-defibrillators (ICD), pacemaker requiring a rate set \>60 beats per minute (bpm), uncontrolled hypertension, New Your Heart Association Class IV, known left ventricular ejection fraction \<30 percent) neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic ulcer disease, or hematological abnormalities.
- Liver disease: Subjects who have unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). Note: Subjects with chronic stable hepatitis B and C are eligible if the subject otherwise meets entry criteria (e.g., presence of hepatitis B surface antigen or positive hepatitis C test result within 3 months of screening). However, subjects with chronic stable hepatitis B are excluded if significant immunosuppressive or cytotoxic agents are administered, due to risk of hepatitis B reactivation, unless the hepatitis B antivirals are administered as outlined in the Chronic Hepatitis B American Association for the Study of Liver Diseases' (AASLD) Practice Guidelines.
- 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.
- Contraindications: Subjects with a history of allergy or hypersensitivity to any of the study medications (e.g. beta-agonists, corticosteroids) 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 investigator, contraindicates the subject's participation will also be excluded.
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (237)
GSK Investigational Site
Riverside, California, 92506, United States
GSK Investigational Site
Sunset, Louisiana, 70584, United States
GSK Investigational Site
Saint Charles, Missouri, 63301, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Wilmington, North Carolina, 28401, United States
GSK Investigational Site
Cincinnati, Ohio, 45231, United States
GSK Investigational Site
Medford, Oregon, 97504, United States
GSK Investigational Site
Erie, Pennsylvania, 16508, United States
GSK Investigational Site
Easley, South Carolina, 29640, United States
GSK Investigational Site
Gaffney, South Carolina, 29340, United States
GSK Investigational Site
Greenville, South Carolina, 29615, 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
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Johnson City, Tennessee, 37601, United States
GSK Investigational Site
Morgantown, West Virginia, 26505, United States
GSK Investigational Site
Dimitrovgrad, 6400, Bulgaria
GSK Investigational Site
Pleven, 5800, Bulgaria
GSK Investigational Site
Plovdiv, 4000, Bulgaria
GSK Investigational Site
Rousse, 7000, Bulgaria
GSK Investigational Site
Sofia, 1202, Bulgaria
GSK Investigational Site
Sofia, 1431, Bulgaria
GSK Investigational Site
Varna, 9000, Bulgaria
GSK Investigational Site
Vidin, 3700, Bulgaria
GSK Investigational Site
Aschaffenburg, Bavaria, 63739, Germany
GSK Investigational Site
Munich, Bavaria, 80339, Germany
GSK Investigational Site
Munich, Bavaria, 80539, Germany
GSK Investigational Site
Rüdersdorf, Brandenburg, 15562, Germany
GSK Investigational Site
Frankfurt am Main, Hesse, 60596, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30159, Germany
GSK Investigational Site
Hanover, Lower Saxony, 30173, Germany
GSK Investigational Site
Osnabrück, Lower Saxony, 49074, Germany
GSK Investigational Site
Essen, North Rhine-Westphalia, 45359, Germany
GSK Investigational Site
Goch, North Rhine-Westphalia, 47574, Germany
GSK Investigational Site
Delitzsch, Saxony, 04509, Germany
GSK Investigational Site
Leipzg, Saxony, 04109, Germany
GSK Investigational Site
Leipzig, Saxony, 04275, Germany
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112, Germany
GSK Investigational Site
Geesthacht, Schleswig-Holstein, 21502, Germany
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552, Germany
GSK Investigational Site
Berlin, 10367, Germany
GSK Investigational Site
Berlin, 10717, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 12203, Germany
GSK Investigational Site
Aichi, 454-8502, Japan
GSK Investigational Site
Aichi, 455-8510, Japan
GSK Investigational Site
Aichi, 457-8511, Japan
GSK Investigational Site
Aichi, 460-0001, Japan
GSK Investigational Site
Aichi, 471-8513, Japan
GSK Investigational Site
Aichi, 489-8642, Japan
GSK Investigational Site
Chiba, 278-0004, Japan
GSK Investigational Site
Chiba, 296-8602, Japan
GSK Investigational Site
Ehime, 791-0281, Japan
GSK Investigational Site
Fukuoka, 802-0052, Japan
GSK Investigational Site
Fukuoka, 802-0083, Japan
GSK Investigational Site
Fukuoka, 811-1394, Japan
GSK Investigational Site
Fukuoka, 815-8588, Japan
GSK Investigational Site
Fukuoka, 816-0813, Japan
GSK Investigational Site
Fukuoka, 820-8505, Japan
GSK Investigational Site
Fukuoka, 832-0059, Japan
GSK Investigational Site
Gifu, 500-8523, Japan
GSK Investigational Site
Gifu, 500-8717, Japan
GSK Investigational Site
Gifu, 506-8550, Japan
GSK Investigational Site
Gifu, 509-6134, Japan
GSK Investigational Site
Gunma, 372-0831, Japan
GSK Investigational Site
Hiroshima, 722-8503, Japan
GSK Investigational Site
Hiroshima, 732-0052, Japan
GSK Investigational Site
Hiroshima, 734-8530, Japan
GSK Investigational Site
Hiroshima, 735-8585, Japan
GSK Investigational Site
Hokkaido, 001-0901, Japan
GSK Investigational Site
Hokkaido, 040-8611, Japan
GSK Investigational Site
Hokkaido, 053-8506, Japan
GSK Investigational Site
Hokkaido, 060-0033, Japan
GSK Investigational Site
Hokkaido, 062-8618, Japan
GSK Investigational Site
Hokkaido, 063-0005, Japan
GSK Investigational Site
Hokkaido, 064-0801, Japan
GSK Investigational Site
Hokkaido, 064-0915, Japan
GSK Investigational Site
Hokkaido, 070-8644, Japan
GSK Investigational Site
Hokkaido, 071-8132, Japan
GSK Investigational Site
Hokkaido, 080-0013, Japan
GSK Investigational Site
Hokkaido, 080-0805, Japan
GSK Investigational Site
Hyōgo, 650-0047, Japan
GSK Investigational Site
Hyōgo, 664-8540, Japan
GSK Investigational Site
Hyōgo, 672-8064, Japan
GSK Investigational Site
Hyōgo, 675-8611, Japan
GSK Investigational Site
Hyōgo, 678-0239, Japan
GSK Investigational Site
Ibaraki, 310-0015, Japan
GSK Investigational Site
Ibaraki, 317-0077, Japan
GSK Investigational Site
Ibaraki, 319-1113, Japan
GSK Investigational Site
Ishikawa, 920-8530, Japan
GSK Investigational Site
Ishikawa, 920-8610, Japan
GSK Investigational Site
Ishikawa, 920-8650, Japan
GSK Investigational Site
Ishikawa, 921-8105, Japan
GSK Investigational Site
Ishikawa, 923-8560, Japan
GSK Investigational Site
Kagawa, 760-0018, Japan
GSK Investigational Site
Kagawa, 760-8538, Japan
GSK Investigational Site
Kagawa, 761-8073, Japan
GSK Investigational Site
Kagawa, 762-8550, Japan
GSK Investigational Site
Kanagawa, 232-0024, Japan
GSK Investigational Site
Kanagawa, 232-0066, Japan
GSK Investigational Site
Kanagawa, 239-0821, Japan
GSK Investigational Site
Kanagawa, 251-8550, Japan
GSK Investigational Site
Kanagawa, 254-8502, Japan
GSK Investigational Site
Kochi, 780-8077, Japan
GSK Investigational Site
Kochi, 783-8505, Japan
GSK Investigational Site
Kumamoto, 861-1196, Japan
GSK Investigational Site
Kumamoto, 862-0954, Japan
GSK Investigational Site
Kyoto, 601-1495, Japan
GSK Investigational Site
Kyoto, 601-8206, Japan
GSK Investigational Site
Kyoto, 607-8062, Japan
GSK Investigational Site
Kyoto, 612-0026, Japan
GSK Investigational Site
Kyoto, 615-8087, Japan
GSK Investigational Site
Mie, 514-1101, Japan
GSK Investigational Site
Mie, 515-8544, Japan
GSK Investigational Site
Miyagi, 980-8574, Japan
GSK Investigational Site
Miyagi, 981-8563, Japan
GSK Investigational Site
Miyagi, 983-8520, Japan
GSK Investigational Site
Miyagi, 984-8560, Japan
GSK Investigational Site
Miyagi, 986-8522, Japan
GSK Investigational Site
Miyagi, 989-1253, Japan
GSK Investigational Site
Nagano, 390-0872, Japan
GSK Investigational Site
Niigata, 950-2085, Japan
GSK Investigational Site
Numakunai, 024-8506, Japan
GSK Investigational Site
Okayama, 702-8055, Japan
GSK Investigational Site
Okayama, 711-0921, Japan
GSK Investigational Site
Okinawa, 901-0243, Japan
GSK Investigational Site
Okinawa, 901-2121, Japan
GSK Investigational Site
Okinawa, 901-2132, Japan
GSK Investigational Site
Okinawa, 904-2143, Japan
GSK Investigational Site
Okinawa, 904-2293, Japan
GSK Investigational Site
Osaka, 530-0001, Japan
GSK Investigational Site
Osaka, 530-8480, Japan
GSK Investigational Site
Osaka, 533-0024, Japan
GSK Investigational Site
Osaka, 564-0013, Japan
GSK Investigational Site
Osaka, 570-8540, Japan
GSK Investigational Site
Osaka, 573-0153, Japan
GSK Investigational Site
Osaka, 576-0041, Japan
GSK Investigational Site
Osaka, 591-8037, Japan
GSK Investigational Site
Osaka, 591-8555, Japan
GSK Investigational Site
Osaka, 596-8501, Japan
GSK Investigational Site
Ōita, 870-0921, Japan
GSK Investigational Site
Ōita, 876-0813, Japan
GSK Investigational Site
Saitama, 349-1105, Japan
GSK Investigational Site
Shizuoka, 430-8525, Japan
GSK Investigational Site
Shizuoka, 434-8511, Japan
GSK Investigational Site
Tokyo, 103-0027, Japan
GSK Investigational Site
Tokyo, 103-0028, Japan
GSK Investigational Site
Tokyo, 104-8560, Japan
GSK Investigational Site
Tokyo, 134-0083, Japan
GSK Investigational Site
Tokyo, 140-0011, Japan
GSK Investigational Site
Tokyo, 140-0013, Japan
GSK Investigational Site
Tokyo, 153-0051, Japan
GSK Investigational Site
Tokyo, 158-8531, Japan
GSK Investigational Site
Tokyo, 171-0014, Japan
GSK Investigational Site
Tokyo, 187-0002, Japan
GSK Investigational Site
Tokyo, 190-0014, Japan
GSK Investigational Site
Tokyo, 194-0023, Japan
GSK Investigational Site
Tokyo, 198-0042, Japan
GSK Investigational Site
Tokyo, 204-8522, Japan
GSK Investigational Site
Toyama, 930-0982, Japan
GSK Investigational Site
Toyama, 931-8553, Japan
GSK Investigational Site
Toyama, 937-0042, Japan
GSK Investigational Site
Toyama, 938-8502, Japan
GSK Investigational Site
Toyama, 939-8511, Japan
GSK Investigational Site
Yamaguchi, 755-0241, Japan
GSK Investigational Site
Bialystok, 15-044, Poland
GSK Investigational Site
Gdynia, 81-384, Poland
GSK Investigational Site
Krakow, 31-011, Poland
GSK Investigational Site
Krakow, 31-024, Poland
GSK Investigational Site
Lodz, 90-242, Poland
GSK Investigational Site
Skierniewice, 96-100, Poland
GSK Investigational Site
Warsaw, 01-192, Poland
GSK Investigational Site
Wroclaw, 50-088, Poland
GSK Investigational Site
Bacau, 600252, Romania
GSK Investigational Site
Brasov, 500118, Romania
GSK Investigational Site
Brăila, 810003, Romania
GSK Investigational Site
Cluj-Napoca, 400371, Romania
GSK Investigational Site
Comuna Alexandru Cel Bun, 617507, Romania
GSK Investigational Site
Craiova, 200515, Romania
GSK Investigational Site
Iași, 700115, Romania
GSK Investigational Site
Ploieşti, 100184, Romania
GSK Investigational Site
Ploieşti, 100379, Romania
GSK Investigational Site
Suceava, 720284, Romania
GSK Investigational Site
Chelyabinsk, 454106, Russia
GSK Investigational Site
Izhevsk, 426063, Russia
GSK Investigational Site
Kemerovo, 650000, Russia
GSK Investigational Site
Kemerovo, 650002, Russia
GSK Investigational Site
Khantymansiysk, 628012, Russia
GSK Investigational Site
Moscow, 115 280, Russia
GSK Investigational Site
Moscow, 125315, Russia
GSK Investigational Site
Novosibirsk, 630089, Russia
GSK Investigational Site
Novosibirsk, 630099, Russia
GSK Investigational Site
Novosibirsk, 630102, Russia
GSK Investigational Site
Saint Petersburg, 194356, Russia
GSK Investigational Site
Saint Petersburg, 195271, Russia
GSK Investigational Site
Saint Petersburg, 198216, Russia
GSK Investigational Site
Saint Petersburg, 198260, Russia
GSK Investigational Site
Saint Petesburg, 195030, Russia
GSK Investigational Site
Port Elizabeth, Eastern Cape, 6014, South Africa
GSK Investigational Site
Welkom, Free State, 9460, South Africa
GSK Investigational Site
Meyerspark, Gauteng, 0184, South Africa
GSK Investigational Site
Pretoria, Gauteng, 0183, South Africa
GSK Investigational Site
Bellville, 7530, South Africa
GSK Investigational Site
Bloemfontein, 9301, South Africa
GSK Investigational Site
Cape Town, 7572, South Africa
GSK Investigational Site
Durban, 4001, South Africa
GSK Investigational Site
Gatesville, 7764, South Africa
GSK Investigational Site
Mowbray, 7700, South Africa
GSK Investigational Site
Tygerberg, 7505, South Africa
GSK Investigational Site
Bucheon-si, 420-717, South Korea
GSK Investigational Site
Daegu, 705-717, South Korea
GSK Investigational Site
Incheon, 403-720, South Korea
GSK Investigational Site
Kangwon-do, 220-701, South Korea
GSK Investigational Site
Seoul, 100-032, South Korea
GSK Investigational Site
Seoul, 130-709, South Korea
GSK Investigational Site
Seoul, 136-705, South Korea
GSK Investigational Site
Seoul, 140-743, South Korea
GSK Investigational Site
Seoul, 150-713, South Korea
GSK Investigational Site
Seoul, 156-755, South Korea
GSK Investigational Site
Keelung, 20401, Taiwan
GSK Investigational Site
New Taipei City, 23148, Taiwan
GSK Investigational Site
Taichung, 404, Taiwan
GSK Investigational Site
Taichung, 40705, Taiwan
GSK Investigational Site
Taichung, 407, Taiwan
GSK Investigational Site
Taichung, 427, Taiwan
GSK Investigational Site
Dnipropetrovsk, 49051, Ukraine
GSK Investigational Site
Kharkiv, 61002, Ukraine
GSK Investigational Site
Kharkiv, 61035, Ukraine
GSK Investigational Site
Kiev, 03680, Ukraine
GSK Investigational Site
Kremenchuk, 39617, Ukraine
GSK Investigational Site
Kyiv, 02232, Ukraine
GSK Investigational Site
Kyiv, 03038, Ukraine
GSK Investigational Site
Kyiv, 03049, Ukraine
GSK Investigational Site
Mykolayiv, 54003, Ukraine
GSK Investigational Site
Odesa, 65025, Ukraine
GSK Investigational Site
Vinnytsia, 21029, Ukraine
Related Publications (1)
Siler TM, Nagai A, Scott-Wilson CA, Midwinter DA, Crim C. A randomised, phase III trial of once-daily fluticasone furoate/vilanterol 100/25 mug versus once-daily vilanterol 25 mug to evaluate the contribution on lung function of fluticasone furoate in the combination in patients with COPD. Respir Med. 2017 Feb;123:8-17. doi: 10.1016/j.rmed.2016.12.001. Epub 2016 Dec 2.
PMID: 28137501DERIVED
Related Links
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
April 3, 2014
First Posted
April 7, 2014
Study Start
April 7, 2014
Primary Completion
July 8, 2015
Study Completion
July 8, 2015
Last Updated
January 24, 2018
Results First Posted
April 13, 2016
Record last verified: 2018-01
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.