A 6-month Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT01053988 | Completed Phase 3 Results

• 1 other identifier: 112206
• Study Type: interventional
• Target: 1,031
• Locations: 10 countries
• Sites: 132

Brief Summary

The Purpose of this study is to assess the efficacy and safety of two strengths of the FF/GW642444 Inhalation Powder in subjects with chronic obstructive pulmonary disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Safety; Chronic Obstructive Pulmonary Disease; Efficacy; FEV1; COPD

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours Post-dose at Day 168

  Co-Primary Endpoint: 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. Serial FEV1 measurements were taken electronically by spirometry at BL, weeks 2, 8, 12, and 84 (Day 168). Weighted mean (WM) was calculated using the 0 - 4 h post-dose FEV1 measurements that included the pre-dose (Day 1: 30 minutes \[min\] and 5 min prior to dosing; other serial visits:23 and 24 h after previous morning dose) and post-dose (5, 15, and 30 min and 1, 2, and 4 h) assessments. BL FEV1 is the mean of the two assessments made 30 and 5 min pre-dose at Day 1. WM change from BL was the WM at the visit minus the BL value. Analysis was performed using a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL- mean of the two assessments made 30 and 5 min pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

  Baseline (BL) to Day 168

• Change From Baseline in Clinic Visit Trough (Pre-bronchodilator and Pre-dose) FEV1 at Day 169

  Co-Primary Endpoint: 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, 7, 14, 28, 56, 84, 112, 140, 168, and 169. BL was defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes 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, smoking status at screening (stratum), BL - mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1, centre grouping, Day, Day by BL and Day by treatment interactions.

  Baseline to Day 169

Secondary Outcomes (3)

• Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168

  Baseline to Day 168

• Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1

  Baseline and Day 1

• Time to Onset (Increase of 100 Milliliter [mL] From Baseline in 0-4 Hours Post-dose FEV1) on Treatment Day 1

  Baseline and Day 1

Study Arms (5)

FF/GW642444 Inhalation Powder

EXPERIMENTAL

Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)

Drug: FF/GW642444 Inhalation Powder

FF Inhalation Powder

EXPERIMENTAL

Inhaled Corticosteroid (ICS)

Drug: FF Inhalation Powder

GW642444 Inhalation Powder

EXPERIMENTAL

Long Acting Beta Agonist(LABA)

Drug: GW642444 Inhalation Powder

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

FF/GW642444 Inhalation Pwdr

EXPERIMENTAL

Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)

Drug: FF/GW642444 Inhalation Powder

Interventions

FF/GW642444 Inhalation Powder DRUG

Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD

Also known as: FF Inhalation Powder, Placebo, GW642444 Inhalation Powder

FF/GW642444 Inhalation Powder; FF/GW642444 Inhalation Pwdr

FF Inhalation Powder DRUG

Inhaled Corticosteroid (ICS)

FF Inhalation Powder

GW642444 Inhalation Powder DRUG

Long Acting Beta Agonist(LABA)

GW642444 Inhalation Powder

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 OR
• Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the acceptable contraceptive methods defined in the protocol
• 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 \[Celli, 2004\]
• Tobacco use: Subjects with a current or prior history of ≥10 pack-years of cigarette smoking at Screening (Visit 1).
• Severity of Disease: Subjects with a Screening (Visit 1) measured post-albuterol/salbutamol:
• FEV1/FVC ratio of ≤0.70 and
• FEV1 ≤70% of predicted normal values
• Dyspnea: Achieved a score of ≥2 on the Modified Medical Research Council Dyspnea Scale (mMRC) at Screening (Visit 1).

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
• 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.
• Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of Visit 1.
• Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of the following in the 6 weeks prior to Visit 1: Acute worsening of COPD that is managed by subject with 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 Visit 1.
• 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.
• 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 medication or components of the inhalation powder

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (132)

GSK Investigational Site

Mobile, Alabama, 36608, United States

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GSK Investigational Site

Montgomery, Alabama, 36106, United States

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Phoenix, Arizona, 85032, United States

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Scottsdale, Arizona, 85258, United States

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Encinitas, California, 92024, United States

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GSK Investigational Site

Rancho Mirage, California, 92270, United States

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Riverside, California, 92506, United States

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San Diego, California, 92117, United States

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Sepulveda, California, 91343, United States

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Clearwater, Florida, 33755, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33125, United States

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Orlando, Florida, 32822, United States

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Panama City, Florida, 32405, United States

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Tamarac, Florida, 33321, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30342, United States

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Austell, Georgia, 30106, United States

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Marietta, Georgia, 30060, United States

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Stockbridge, Georgia, 30281, United States

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Coeur d'Alene, Idaho, 83814, United States

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Evansville, Indiana, 47714, United States

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Wichita, Kansas, 67205, United States

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Wichita, Kansas, 67207, United States

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Hazard, Kentucky, 41701, United States

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Madisonville, Kentucky, 42431, United States

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New Orleans, Louisiana, 70115, United States

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Sunset, Louisiana, 70584, United States

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Baltimore, Maryland, 21224, United States

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Fall River, Massachusetts, 02720, United States

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Livonia, Michigan, 48152, United States

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Edina, Minnesota, 55438, United States

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Minneapolis, Minnesota, 55407, United States

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St Louis, Missouri, 63117, United States

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St Louis, Missouri, 63141, United States

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Charlotte, North Carolina, 28207, United States

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Wilmington, North Carolina, 28401, United States

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Columbus, Ohio, 43215, United States

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Medford, Oregon, 97504, United States

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Charleston, South Carolina, 29406-7108, United States

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Gaffney, South Carolina, 29340, United States

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Greenville, South Carolina, 29615, United States

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Pelzer, South Carolina, 29669, United States

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Spartanburg, South Carolina, 29303, United States

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San Antonio, Texas, 78229, United States

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Wichita Falls, Texas, 76309, United States

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Valparaíso, Región de Valparaíso, 2341131, Chile

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Puente Alto - Santiago, Región Metro de Santiago, 8207257, Chile

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Santiago, Región Metro de Santiago, 7500691, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7601003, Chile

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Santiago, 8380453, Chile

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Pärnu, 80010, Estonia

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Tallinn, 10138, Estonia

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Tallinn, 13619, Estonia

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Tartu, 51014, Estonia

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GSK Investigational Site

Deggingen, Baden-Wurttemberg, 73326, Germany

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Schwetzingen, Baden-Wurttemberg, 68723, Germany

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Aschaffenburg, Bavaria, 63739, Germany

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Erlangen, Bavaria, 91052, Germany

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Munich, Bavaria, 80802, Germany

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Munich, Bavaria, 80809, Germany

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Rüdersdorf, Brandenburg, 15562, Germany

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Eschwege, Hesse, 37269, Germany

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Kassel, Hesse, 34121, Germany

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Rüsselsheim am Main, Hesse, 65428, Germany

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Hanover, Lower Saxony, 30159, Germany

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Hanover, Lower Saxony, 30167, Germany

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Dortmund, North Rhine-Westphalia, 44263, Germany

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Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

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Mainz, Rhineland-Palatinate, 55131, Germany

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Görlitz, Saxony, 02826, Germany

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Leipzig, Saxony, 04103, Germany

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Magdeburg, Saxony-Anhalt, 39112, Germany

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Lübeck, Schleswig-Holstein, 23552, Germany

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Schmölln, Thuringia, 04626, Germany

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Hamburg, 20253, Germany

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Hamburg, 20354, Germany

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Fukuoka, 815-8588, Japan

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Fukuoka, 832-0059, Japan

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Ibaraki, 319-1113, Japan

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Kagawa, 762-0031, Japan

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Kanagawa, 232-0066, Japan

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Nagano, 382-0091, Japan

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Osaka, 596-8501, Japan

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Shizuoka, 438-8550, Japan

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Tokyo, 145-0063, Japan

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Tokyo, 187-0031, Japan

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Guadalajara, Jalisco, 44100, Mexico

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Monterrey, Nuevo León, 64060, Mexico

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Monterrey, Nuevo León, 64460, Mexico

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Monterrey NL, Nuevo León, 64718, Mexico

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Mexico City, 07760, Mexico

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Iloilo City, 5000, Philippines

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Lipa City, 4217, Philippines

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Pasig, 1600, Philippines

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Quezon City, 1100, Philippines

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Quezon City, 1101, Philippines

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Bialystok, 15-084, Poland

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Bialystok, 15-540, Poland

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Gdansk, 80-405, Poland

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Grudziądz, 86-300, Poland

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Krakow, 31-023, Poland

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Lodz, 93-329, Poland

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Lodz, 93-504, Poland

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Lublin, 20-954, Poland

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Ostrów Wielkopolski, 63-400, Poland

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Poznan, 60-569, Poland

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Wilkowice, 43-365, Poland

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Wodzisław Śląski, 44-300, Poland

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Zabrze, 41-800, Poland

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Barnaul, 656 045, Russia

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Irkutsk, 664005, Russia

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Moscow, 119620, Russia

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Pyatigorsk, 357538, Russia

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Samara, 443079, Russia

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Shakhty, Rostov Region, 346510, Russia

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Tomsk, 634001, Russia

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Tyumen, 625023, Russia

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Ufa, 450071, Russia

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GSK Investigational Site

Yaroslavl, 150062, Russia

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Yekaterinburg, 620109, Russia

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GSK Investigational Site

Bucheon-si, 420-767, South Korea

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GSK Investigational Site

Daegu, 705-717, South Korea

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GSK Investigational Site

Gyeonggi-do, 431-070, South Korea

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GSK Investigational Site

Incheon, 405-760, South Korea

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GSK Investigational Site

Kangwon-do, 220-701, South Korea

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GSK Investigational Site

Seoul, 130-848, South Korea

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Seoul, 136-705, South Korea

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Seoul, 143-729, South Korea

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Seoul, 152-703, South Korea

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GSK Investigational Site

Uijeongbu-si, Kyonggi-do, 480-130, South Korea

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Related Publications (3)

• Kerwin EM, Scott-Wilson C, Sanford L, Rennard S, Agusti A, Barnes N, Crim C. A randomised trial of fluticasone furoate/vilanterol (50/25 mug; 100/25 mug) on lung function in COPD. Respir Med. 2013 Apr;107(4):560-9. doi: 10.1016/j.rmed.2012.12.014. Epub 2013 Jan 23.

  PMID: 23352226 BACKGROUND

• Yang L, Llanos-Paez C, Yang S, Ambery C, Berges A, Kjellsson MC, Karlsson MO. A Combined Model-Based Meta-Analysis of Aggregated and Individual FEV1 Data From Randomized COPD Trials. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70059. doi: 10.1002/psp4.70059. Epub 2025 Jun 19.

  PMID: 40536286 DERIVED

• Svedsater 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: 24314123 DERIVED

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

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: January 14, 2010
• First Posted: January 22, 2010
• Study Start: October 5, 2009
• Primary Completion: February 1, 2011
• Study Completion: April 14, 2011
• Last Updated: July 12, 2018
• Results First Posted: August 15, 2013

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

PL (13); RU (11); ES (4); ME (5); CL (5); PH (5); JP (10); KR (10); DE (22); US (47)