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)

A 24-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components Delivered Once Daily (AM) Via a Novel Dry Powder Inhaler Compared With Placebo in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

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)

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Placebo; Drug: FF/GW642444 Inhalation Powder; Drug: FF Inhalation Powder; Drug: GW642444 Inhalation Powder

• Study Type: Interventional
• Enrollment (Actual): 1031
• Phase: Phase 3

Contacts and Locations

Study Locations

• Chile
  • Santiago, Chile, 8380453
    • GSK Investigational Site
  • Región Metro De Santiago
    • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
      • GSK Investigational Site
    • Santiago, Región Metro De Santiago, Chile, 7500691
      • GSK Investigational Site
    • Santiago, Región Metro De Santiago, Chile, 7601003
      • GSK Investigational Site
  • Valparaíso
    • Valparaiso, Valparaíso, Chile, 2341131
      • GSK Investigational Site
• Estonia
  • Parnu, Estonia, 80010
    • GSK Investigational Site
  • Tallinn, Estonia, 13619
    • GSK Investigational Site
  • Tallinn, Estonia, 10138
    • GSK Investigational Site
  • Tartu, Estonia, 51014
    • GSK Investigational Site
• Germany
  • Hamburg, Germany, 20253
    • GSK Investigational Site
  • Hamburg, Germany, 20354
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Deggingen, Baden-Wuerttemberg, Germany, 73326
      • GSK Investigational Site
    • Schwetzingen, Baden-Wuerttemberg, Germany, 68723
      • GSK Investigational Site
  • Bayern
    • Aschaffenburg, Bayern, Germany, 63739
      • GSK Investigational Site
    • Erlangen, Bayern, Germany, 91052
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80802
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80809
      • GSK Investigational Site
  • Brandenburg
    • Ruedersdorf, Brandenburg, Germany, 15562
      • GSK Investigational Site
  • Hessen
    • Eschwege, Hessen, Germany, 37269
      • GSK Investigational Site
    • Kassel, Hessen, Germany, 34121
      • GSK Investigational Site
    • Ruesselsheim, Hessen, Germany, 65428
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30159
      • GSK Investigational Site
    • Hannover, Niedersachsen, Germany, 30167
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Dortmund, Nordrhein-Westfalen, Germany, 44263
      • GSK Investigational Site
    • Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
      • GSK Investigational Site
  • Rheinland-Pfalz
    • Mainz, Rheinland-Pfalz, Germany, 55131
      • GSK Investigational Site
  • Sachsen
    • Goerlitz, Sachsen, Germany, 02826
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
  • Schleswig-Holstein
    • Luebeck, Schleswig-Holstein, Germany, 23552
      • GSK Investigational Site
  • Thueringen
    • Schmoelln, Thueringen, Germany, 04626
      • GSK Investigational Site
• Japan
  • Fukuoka, Japan, 815-8588
    • GSK Investigational Site
  • Fukuoka, Japan, 832-0059
    • GSK Investigational Site
  • Ibaraki, Japan, 319-1113
    • GSK Investigational Site
  • Kagawa, Japan, 762-0031
    • GSK Investigational Site
  • Kanagawa, Japan, 232-0066
    • GSK Investigational Site
  • Nagano, Japan, 382-0091
    • GSK Investigational Site
  • Osaka, Japan, 596-8501
    • GSK Investigational Site
  • Shizuoka, Japan, 438-8550
    • GSK Investigational Site
  • Tokyo, Japan, 145-0063
    • GSK Investigational Site
  • Tokyo, Japan, 187-0031
    • GSK Investigational Site
• Korea, Republic of
  • Bucheon-si,, Korea, Republic of, 420-767
    • GSK Investigational Site
  • Daegu, Korea, Republic of, 705-717
    • GSK Investigational Site
  • Gyeonggi-do, Korea, Republic of, 431-070
    • GSK Investigational Site
  • Incheon, Korea, Republic of, 405-760
    • GSK Investigational Site
  • Kangwon-do, Korea, Republic of, 220-701
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 143-729
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 136-705
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 152-703
    • GSK Investigational Site
  • Seoul, Korea, Republic of, 130-848
    • GSK Investigational Site
  • Uijeongbu-si, Kyonggi-do, Korea, Republic of, 480-130
    • GSK Investigational Site
• Mexico
  • Mexico City, Mexico, 07760
    • GSK Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44100
      • GSK Investigational Site
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • GSK Investigational Site
    • Monterrey, Nuevo León, Mexico, 64060
      • GSK Investigational Site
    • Monterrey NL, Nuevo León, Mexico, 64718
      • GSK Investigational Site
• Philippines
  • Iloilo City, Philippines, 5000
    • GSK Investigational Site
  • Lipa City, Philippines, 4217
    • GSK Investigational Site
  • Pasig City, Philippines, 1600
    • GSK Investigational Site
  • Quezon City, Philippines, 1101
    • GSK Investigational Site
  • Quezon City, Philippines, 1100
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-540
    • GSK Investigational Site
  • Bialystok, Poland, 15-084
    • GSK Investigational Site
  • Gdansk, Poland, 80-405
    • GSK Investigational Site
  • Grudziadz, Poland, 86-300
    • GSK Investigational Site
  • Krakow, Poland, 31-023
    • GSK Investigational Site
  • Lodz, Poland, 93-504
    • GSK Investigational Site
  • Lodz, Poland, 93-329
    • GSK Investigational Site
  • Lublin, Poland, 20-954
    • GSK Investigational Site
  • Ostrow Wielkopolski, Poland, 63-400
    • GSK Investigational Site
  • Poznan, Poland, 60-569
    • GSK Investigational Site
  • Wilkowice, Poland, 43-365
    • GSK Investigational Site
  • Wodzislaw Slaski, Poland, 44-300
    • GSK Investigational Site
  • Zabrze, Poland, 41-800
    • GSK Investigational Site
• Russian Federation
  • Barnaul, Russian Federation, 656 045
    • GSK Investigational Site
  • Ekaterinburg, Russian Federation, 620109
    • GSK Investigational Site
  • Irkutsk, Russian Federation, 664005
    • GSK Investigational Site
  • Moscow, Russian Federation, 119620
    • GSK Investigational Site
  • Pyatigorsk, Russian Federation, 357538
    • GSK Investigational Site
  • Samara, Russian Federation, 443079
    • GSK Investigational Site
  • Shakhty, Rostov Region, Russian Federation, 346510
    • GSK Investigational Site
  • Tomsk, Russian Federation, 634001
    • GSK Investigational Site
  • Tumen, Russian Federation, 625023
    • GSK Investigational Site
  • Ufa, Russian Federation, 450071
    • GSK Investigational Site
  • Yaroslavl, Russian Federation, 150062
    • GSK Investigational Site
• United States
  • Alabama
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
    • Montgomery, Alabama, United States, 36106
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • GSK Investigational Site
    • Scottsdale, Arizona, United States, 85258
      • GSK Investigational Site
  • California
    • Encinitas, California, United States, 92024
      • GSK Investigational Site
    • Rancho Mirage, California, United States, 92270
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • San Diego, California, United States, 92117
      • GSK Investigational Site
    • Sepulveda, California, United States, 91343
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33755
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Maitland, Florida, United States, 32751
      • GSK Investigational Site
    • Miami, Florida, United States, 33125
      • GSK Investigational Site
    • Orlando, Florida, United States, 32822
      • GSK Investigational Site
    • Panama City, Florida, United States, 32405
      • GSK Investigational Site
    • Tamarac, Florida, United States, 33321
      • GSK Investigational Site
    • Winter Park, Florida, United States, 32789
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Austell, Georgia, United States, 30106
      • GSK Investigational Site
    • Marietta, Georgia, United States, 30060
      • GSK Investigational Site
    • Stockbridge, Georgia, United States, 30281
      • GSK Investigational Site
  • Idaho
    • Coeur d'Alene, Idaho, United States, 83814
      • GSK Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67205
      • GSK Investigational Site
  • Kentucky
    • Hazard, Kentucky, United States, 41701
      • GSK Investigational Site
    • Madisonville, Kentucky, United States, 42431
      • GSK Investigational Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70115
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • GSK Investigational Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • GSK Investigational Site
  • Michigan
    • Livonia, Michigan, United States, 48152
      • GSK Investigational Site
  • Minnesota
    • Edina, Minnesota, United States, 55438
      • GSK Investigational Site
    • Minneapolis, Minnesota, United States, 55407
      • GSK Investigational Site
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • GSK Investigational Site
    • Saint Louis, Missouri, United States, 63117
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
  • Ohio
    • Columbus, Ohio, United States, 43215
      • GSK Investigational Site
  • Oregon
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29406-7108
      • GSK Investigational Site
    • Gaffney, South Carolina, United States, 29340
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
    • Pelzer, South Carolina, United States, 29669
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78229
      • GSK Investigational Site
    • Wichita Falls, Texas, United States, 76309
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

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
• Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
• Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol and/or their ipratropium 4 hours prior to spirometry testing at each study visit
• Additional medication: Use of certain medications such as bronchodilators and corticosteroids for the protocol-specified times prior to Visit 1 (the Investigator will discuss the specific medications)
• Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy (LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day. Oxygen prn use (i.e., ≤12 hours per day) is not exclusionary.
• Sleep apnea: Subjects with clinically significant sleep apnea who require use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
• Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
• Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits.
• Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study.
• Prior use of study medication/other investigational drugs
• Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or immediate family members of the aforementioned are excluded from participating in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Placebo
Experimental: FF/GW642444 Inhalation Powder; Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)	Drug: FF/GW642444 Inhalation Powder; Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD; Other Names: Placebo; FF Inhalation Powder; GW642444 Inhalation Powder
Experimental: FF Inhalation Powder; Inhaled Corticosteroid (ICS)	Drug: FF Inhalation Powder; Inhaled Corticosteroid (ICS)
Experimental: GW642444 Inhalation Powder; Long Acting Beta Agonist(LABA)	Drug: GW642444 Inhalation Powder; Long Acting Beta Agonist(LABA)
Experimental: FF/GW642444 Inhalation Pwdr; Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)	Drug: FF/GW642444 Inhalation Powder; Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD; Other Names: Placebo; FF Inhalation Powder; GW642444 Inhalation Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Chronic Respiratory Disease Questionnaire Self-administered Standardized (CRQ-SAS) Dyspnea Score at Day 168	Considered an 'Other' endpoint by FDA. CRQ-SAS measures 4 domains (mastery, fatigue, emotional function, and dyspnea) of functioning of participants with COPD: mastery (amount of control the participant feels he/she has over COPD symptoms); fatigue (how tired the participant feels); emotional function (how anxious/depressed the participant feels); and dyspnea (how short of breath the participant feels during physical activities). Each domain is measured on a scale of 1-7 (1=maximum impairment; 7=no impairment). Each domain score is calculated separately. Current assessment was done only for dyspnea domain. BL scores are the derived scores for each domain and total at Day 1 pre-dose. Change from BL was calculated as the average at each visit minus the BL value. Analysis performed used a repeated measures model with covariates of treatment, smoking status at screening (stratum), BL (derived scores at Day 1 pre-dose), centre grouping, Day, Day by BL and Day by treatment interactions.	Baseline to Day 168
Change From Baseline in Peak Post-dose FEV1 (0-4 Hour) on Day 1	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. BL FEV1 is defined as the mean of the assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then BL was defined as the single pre-dose FEV1 value on Day 1. Peak post-dose FEV1 (0-4 hours) is the maximum post-dose FEV1 recorded over the nominal timepoints of 5, 15 and 30 min, 1, 2 and 4 hours post the Day 1 dose. Change from BL is calculated as the peak post-dose FEV1 (0-4 hour) on Day 1 minus BL FEV1. Analysis performed used an Analysis of Covariance (ANCOVA) 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, and centre grouping.	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	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. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Time to onset on Treatment Day 1 is defined as a 100 mL increase from Baseline in FEV1. Time to increase of 100 mL from Baseline was calculated over the 5, 15, 30 minutes, and 1, 2, and 4 hours time points. A participant who had at least one post-dose FEV1 on Day 1, but did not achieve a 100 mL or more increase from Baseline at any scheduled time-point at which FEV1 was assessed up to and including 4 hours was censored.	Baseline and Day 1

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Respir Med. 2013 Dec;107(12):2094.

Helpful 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.

Study record dates

Study Major Dates

• Study Start: October 5, 2009
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): April 14, 2011

Study Registration Dates

• First Submitted: January 14, 2010
• First Submitted That Met QC Criteria: January 21, 2010
• First Posted (Estimate): January 22, 2010

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Safety; COPD; Efficacy; Chronic Obstructive Pulmonary Disease; FEV1
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 112206

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Individual Participant Data Set
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Informed Consent Form
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Study Protocol
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 112206
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register