Efficacy and Safety Study of Fluticasone Furoate (FF)/GW642444 Inhalation Powder and the Individual Components in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

January 18, 2018 updated by: GlaxoSmithKline

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 subject with Chronic Obstructive Pulmonary Disease (COPD)

Study Overview

Study Type

Interventional

Enrollment (Actual)

1226

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, C1425BEN
        • GSK Investigational Site
      • Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
        • GSK Investigational Site
      • San Miguel de Tucumán, Argentina, 4000
        • GSK Investigational Site
    • Río Negro
      • Cipolletti, Río Negro, Argentina, R8324EMB
        • GSK Investigational Site
      • Brno, Czechia, 625 00
        • GSK Investigational Site
      • Jindrichuv Hradec, Czechia, 377 01
        • GSK Investigational Site
      • Kralupy nad Vltavou, Czechia, 278 01
        • GSK Investigational Site
      • Liberec, Czechia, 460 01
        • GSK Investigational Site
      • Ostrava - Poruba, Czechia, 70868
        • GSK Investigational Site
      • Plzen, Czechia, 301 00
        • GSK Investigational Site
      • Plzen, Czechia, 323 00
        • GSK Investigational Site
      • Praha 8, Czechia, 180 81
        • GSK Investigational Site
      • Praha 8, Czechia, 182 00
        • GSK Investigational Site
      • Rokycany, Czechia, 337 01
        • GSK Investigational Site
      • Tabor, Czechia, 390 19
        • GSK Investigational Site
      • Berlin, Germany, 10367
        • GSK Investigational Site
      • Berlin, Germany, 14057
        • GSK Investigational Site
      • Berlin, Germany, 13086
        • GSK Investigational Site
      • Berlin, Germany, 10117
        • GSK Investigational Site
      • Berlin, Germany, 10717
        • GSK Investigational Site
      • Berlin, Germany, 13125
        • GSK Investigational Site
      • Berlin, Germany, 10787
        • GSK Investigational Site
      • Berlin, Germany, 12203
        • GSK Investigational Site
      • Berlin, Germany, 13581
        • GSK Investigational Site
      • Berlin, Germany, 12043
        • GSK Investigational Site
      • Hamburg, Germany, 22143
        • GSK Investigational Site
      • Hamburg, Germany, 22335
        • GSK Investigational Site
      • Hamburg, Germany, 22299
        • GSK Investigational Site
    • Bayern
      • Muenchen, Bayern, Germany, 80339
        • GSK Investigational Site
    • Hessen
      • Darmstadt, Hessen, Germany, 64287
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60596
        • GSK Investigational Site
      • Frankfurt, Hessen, Germany, 60389
        • GSK Investigational Site
      • Gelnhausen, Hessen, Germany, 63571
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Schwerin, Mecklenburg-Vorpommern, Germany, 19055
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Koeln, Nordrhein-Westfalen, Germany, 51069
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Rhaunen, Rheinland-Pfalz, Germany, 55624
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • GSK Investigational Site
      • Leipzg, Sachsen, Germany, 04109
        • GSK Investigational Site
      • Radebeul, Sachsen, Germany, 01445
        • GSK Investigational Site
    • Schleswig-Holstein
      • Geesthacht, Schleswig-Holstein, Germany, 21502
        • GSK Investigational Site
      • Chiba, Japan, 296-8602
        • GSK Investigational Site
      • Ehime, Japan, 791-0281
        • GSK Investigational Site
      • Fukuoka, Japan, 811-3195
        • GSK Investigational Site
      • Ibaraki, Japan, 306-0433
        • GSK Investigational Site
      • Kyoto, Japan, 602-8026
        • GSK Investigational Site
      • Kyoto, Japan, 612-0026
        • GSK Investigational Site
      • Mie, Japan, 514-1101
        • GSK Investigational Site
      • Okinawa, Japan, 901-2132
        • GSK Investigational Site
      • Okinawa, Japan, 904-2143
        • GSK Investigational Site
      • Osaka, Japan, 530-0001
        • GSK Investigational Site
      • Osaka, Japan, 591-8555
        • GSK Investigational Site
      • Shizuoka, Japan, 434-8511
        • GSK Investigational Site
      • Tokyo, Japan, 158-0083
        • GSK Investigational Site
      • Czestochowa, Poland, 42-200
        • GSK Investigational Site
      • Gdansk, Poland, 80-952
        • GSK Investigational Site
      • Gidle, Poland, 97-540
        • GSK Investigational Site
      • Gizycko, Poland, 11-500
        • GSK Investigational Site
      • Lomza, Poland, 18-400
        • GSK Investigational Site
      • Piekary Slaskie, Poland, 41-940
        • GSK Investigational Site
      • Szczecin, Poland, 71-124
        • GSK Investigational Site
      • Warszawa, Poland, 01-138
        • GSK Investigational Site
      • Warszawa, Poland, 02-097
        • GSK Investigational Site
      • Brasov, Romania, 500112
        • GSK Investigational Site
      • Bucharest, Romania, 050159
        • GSK Investigational Site
      • Bucharest, Romania, 020125
        • GSK Investigational Site
      • Bucharest, Romania, 011794
        • GSK Investigational Site
      • Bucharest, Romania, 030317
        • GSK Investigational Site
      • Bucharest, Romania, 020201
        • GSK Investigational Site
      • Bucharest, Romania, 031298
        • GSK Investigational Site
      • Bucuresti, Romania, 70000
        • GSK Investigational Site
      • Bucuresti, Romania, 010816
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400371
        • GSK Investigational Site
      • Cluj-Napoca, Romania, 400349
        • GSK Investigational Site
      • Constanta, Romania, 900002
        • GSK Investigational Site
      • Deva, Romania, 330160
        • GSK Investigational Site
      • Iasi, Romania, 700115
        • GSK Investigational Site
      • Popesti Leordeni, Romania, 077160
        • GSK Investigational Site
      • Suceava, Romania, 720284
        • GSK Investigational Site
      • Timisoara, Romania, 300310
        • GSK Investigational Site
      • Chelyabinsk, Russian Federation, 454106
        • GSK Investigational Site
      • Ivanovo, Russian Federation, 153005
        • GSK Investigational Site
      • Kazan, Russian Federation, 420015
        • GSK Investigational Site
      • Kemerovo, Russian Federation, 650000
        • GSK Investigational Site
      • Krasnoyarsk, Russian Federation, 660022
        • GSK Investigational Site
      • Moscow, Russian Federation, 105077
        • GSK Investigational Site
      • Moscow, Russian Federation, 127018
        • GSK Investigational Site
      • Moscow, Russian Federation, 119 048
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 193231
        • GSK Investigational Site
      • Yaroslavl, Russian Federation
        • GSK Investigational Site
      • Dnipropetrovsk, Ukraine, 49051
        • GSK Investigational Site
      • Kharkiv, Ukraine, 61035
        • GSK Investigational Site
      • Kiev, Ukraine, 03680
        • GSK Investigational Site
      • Kyiv, Ukraine, 02091
        • GSK Investigational Site
      • Kyiv, Ukraine, 03038
        • GSK Investigational Site
      • Kyiv, Ukraine, 03115
        • GSK Investigational Site
      • Kyiv, Ukraine, 01114
        • GSK Investigational Site
      • Odesa, Ukraine, 65117
        • GSK Investigational Site
      • Simferopol, Ukraine, 95043
        • GSK Investigational Site
      • Vinnytsia, Ukraine, 21029
        • GSK Investigational Site
    • Alabama
      • Birmingham, Alabama, United States, 35235
        • GSK Investigational Site
      • Jasper, Alabama, United States, 35501
        • GSK Investigational Site
    • California
      • Lakewood, California, United States, 90712
        • GSK Investigational Site
      • Long Beach, California, United States, 90808
        • GSK Investigational Site
      • Los Angeles, California, United States, 90048
        • GSK Investigational Site
      • Monterey Park, California, United States, 91754
        • GSK Investigational Site
      • National City, California, United States, 91950
        • GSK Investigational Site
      • Oxnard, California, United States, 93030-5841
        • GSK Investigational Site
      • San Diego, California, United States, 92120
        • GSK Investigational Site
      • Santa Monica, California, United States, 90404
        • GSK Investigational Site
    • Delaware
      • Wilmington, Delaware, United States, 19805
        • GSK Investigational Site
    • Florida
      • Bay Pines, Florida, United States, 33744
        • GSK Investigational Site
      • Brandon, Florida, United States, 33511
        • GSK Investigational Site
      • Clearwater, Florida, United States, 33756
        • GSK Investigational Site
      • Cocoa, Florida, United States, 32927
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • GSK Investigational Site
      • Pensacola, Florida, United States, 32503
        • GSK Investigational Site
    • Georgia
      • Decatur, Georgia, United States
        • GSK Investigational Site
      • Gainesville, Georgia, United States
        • GSK Investigational Site
      • Martinez, Georgia, United States, 30907
        • GSK Investigational Site
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • GSK Investigational Site
    • Maryland
      • Wheaton, Maryland, United States, 20902
        • GSK Investigational Site
    • Missouri
      • Saint Charles, Missouri, United States, 63301
        • GSK Investigational Site
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • GSK Investigational Site
      • Ocean City, New Jersey, United States, 7712
        • GSK Investigational Site
    • New York
      • Brooklyn, New York, United States, 11229
        • GSK Investigational Site
    • North Carolina
      • Elizabeth City, North Carolina, United States, 27909
        • GSK Investigational Site
      • Statesville, North Carolina, United States, 28625
        • GSK Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45231
        • GSK Investigational Site
      • Dayton, Ohio, United States, 45439
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Investigational Site
      • Tulsa, Oklahoma, United States, 74136-8303
        • GSK Investigational Site
    • Oregon
      • Medford, Oregon, United States, 97504
        • GSK Investigational Site
      • Portland, Oregon, United States, 97213
        • GSK Investigational Site
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • GSK Investigational Site
      • Easley, South Carolina, United States, 29640
        • GSK Investigational Site
      • Gaffney, South Carolina, United States, 29340
        • GSK Investigational Site
      • Orangeburg, South Carolina, United States, 29118
        • GSK Investigational Site
      • Seneca, South Carolina, United States, 29678
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
      • Union, South Carolina, United States, 29379
        • GSK Investigational Site
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
        • GSK Investigational Site
      • New Tazewell, Tennessee, United States, 37825
        • GSK Investigational Site
    • Texas
      • Boerne, Texas, United States, 78006
        • GSK Investigational Site
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • Kingwood, Texas, United States, 77339
        • GSK Investigational Site
      • Temple, Texas, United States, 76508
        • GSK Investigational Site
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • GSK Investigational Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo
EXPERIMENTAL: Fluticasone Furoate Inhalation Powder
Inhaled Corticosteroid (ICS)
Inhaled Corticosteroid (ICS)
EXPERIMENTAL: FF Inhalation Pwdr
Inhaled Corticosteroid (ICS)
Inhaled Corticosteroid (ICS)
EXPERIMENTAL: Fluticasone Furoate/GW642444 Inhalation Powder
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
EXPERIMENTAL: FF/GW642444 Inhalation Pwdr
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA)
Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
EXPERIMENTAL: GW642444 Inhalation Powder
Long Acting Beta Agonist(LABA)
Long Acting Beta Agonist(LABA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Weighted Mean FEV1 Over 0-4 Hours (h) Post-dose at Day 168
Time Frame: Baseline (BL) to 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
Time Frame: Baseline to 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 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
Time Frame: Baseline to 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
Time Frame: Baseline and 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
Time Frame: Baseline and 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

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 19, 2009

Primary Completion (ACTUAL)

February 1, 2011

Study Completion (ACTUAL)

February 8, 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)

January 24, 2018

Last Update Submitted That Met QC Criteria

January 18, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

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. Dataset Specification
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistical Analysis Plan
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Study Protocol
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Informed Consent Form
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annotated Case Report Form
    Information identifier: 112207
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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