A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD (DB2113361)

A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease

This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: GSK573719/GW642444 125/25mcg; Drug: GSK573719 125mcg; Drug: GW642444 25mcg; Drug: Placebo only

Detailed Description

This is a 24-week, phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study.

Eligible subjects will be randomized to GSK573719/GW642444 125/25mcg, GSK573719 125mcg, GW642444 25mcg, and placebo treatment groups in a 3:3:3:2 ratio such that of the planned 1463 total number of randomized subjects approximately 399 subjects will be randomized to each active treatment group and 266 subjects will be randomized to placebo. All treatments will be administered once-daily in the morning by inhalation using a Novel Dry Powder Inhaler (Novel DPI).

There will be a total of 9 study clinic visits conducted on an outpatient basis. Subjects who meet the eligibility criteria at Screening (Visit 1) will complete a 7 to 14 day run-in period followed by a 24-week treatment period. Clinic visits will be at Screening, Randomization (Day 1), Day 2, after 4, 8, 12, 16, and 24-weeks of treatment, and 1 day after the Week 24 Visit (also referred as Treatment Day 169). A follow-up contact for adverse assessment will be conducted by telephone approximately 7 days after Visit 9 or the Early Withdrawal Visit. The total duration of subject participation, including follow-up will be approximately 27 weeks. All subjects will be provided with albuterol/salbutamol for use on an "as-needed" basis throughout the run-in and study treatment periods.

At screening, pre-bronchodilator spirometry testing will be followed by post-albuterol/salbutamol spirometry testing. Post-albuterol/salbutamol FEV1 and FEV1/FVC values will be used to determine subject eligibility. To further characterize bronchodilator responsiveness, post-ipratropium testing will be conducted following completion of post-albuterol/salbutamol spirometry.

Spirometry will be conducted at each post-randomization clinic visit. Six hour post-dose serial spirometry will be conducted at Visits 2, 4, 6, and 8. Trough spirometry will be obtained 23 and 24 hours after the previous day's dose of blinded study medication at Visits 3 to 9. All subjects will be provided with an electronic diary (eDiary) for completion daily in the evening throughout the run-in and treatment periods. Subjects will use the eDiary to record dyspnea scores using the Shortness of Breath with Daily Activities instrument (SOBDA), daily use of supplemental albuterol/salbutamol as either puffs/day from a metered-dose inhaler (MDI) and/or nebules used per day, and any healthcare contacts related to COPD.

Additional assessments of dyspnea will be obtained using the Baseline and Transition Dyspnea Index (BDI/TDI) which is an interviewer based instrument. At Visit 2, the severity of dyspnea at baseline will be assessed using the BDI. At subsequent visits (Visits 4, 6, and 8) change from baseline will be assessed using the TDI. Disease specific health status will be evaluated using the subject-completed St. George's Respiratory Questionnaire (SGRQ). The SGRQ will be completed at Visits 2, 4, 6, and 8. Administration of the SGRQ and BDI/TDI should be done prior to spirometry testing.

The occurrence of adverse events will be evaluated throughout the study beginning at Visit 2. SAEs will be collected over the same time period as for AEs. However, any SAEs assessed as related to study participation (e.g., study treatment, protocol-mandated procedures, invasive tests, or change in existing therapy) or related to a GSK concomitant medication, will be recorded from the time a subject consents to participate in the study up to and including any follow up contact.

Additional safety assessments of vital signs (blood pressure and pulse rate), 12-lead ECGs and standard clinical laboratory tests (hematology and chemistry) will be obtained at selected clinic visits. Blood samples for population pharmacokinetic analyses will be obtained.

At selected study sites, a subset of approximately 198 subjects will perform 24-hour serial spirometry during the study for evaluation of lung function over the dosing period. In conjunction with the serial spirometry, this subset of subjects will also perform 24 hour Holter monitoring and provide blood samples for PK analysis.

• Study Type: Interventional
• Enrollment (Actual): 1493
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Aalst, Belgium, 9300
    • GSK Investigational Site
  • Edegem, Belgium, 2650
    • GSK Investigational Site
  • Genk, Belgium, 3600
    • GSK Investigational Site
  • Kortrijk, Belgium, 8500
    • GSK Investigational Site
  • Liège, Belgium, 4000
    • GSK Investigational Site
• Denmark
  • Aalborg, Denmark, 9100
    • GSK Investigational Site
  • Hvidovre, Denmark, 2650
    • GSK Investigational Site
  • København, Denmark, 2400
    • GSK Investigational Site
  • Naestved, Denmark, 4700
    • GSK Investigational Site
  • Odense C, Denmark, 5000
    • GSK Investigational Site
  • Roedovre, Denmark, 2610
    • GSK Investigational Site
  • Roskilde, Denmark, 4000
    • GSK Investigational Site
• Estonia
  • Haapsalu, Estonia, 90502
    • GSK Investigational Site
  • Parnu, Estonia, 80010
    • GSK Investigational Site
  • Rakvere, Estonia, 44316
    • GSK Investigational Site
  • Tallinn, Estonia, 10117
    • GSK Investigational Site
  • Tallinn, Estonia, 10138
    • GSK Investigational Site
  • Tartu, Estonia, 51014
    • GSK Investigational Site
• France
  • Lyon cedex 04, France, 69317
    • GSK Investigational Site
  • Montauban cedex, France, 82017
    • GSK Investigational Site
  • Nice, France, 06000
    • GSK Investigational Site
  • Perpignan, France, 66000
    • GSK Investigational Site
  • Reims Cedex, France, 51092
    • GSK Investigational Site
  • Tarbes Cedex 09, France, 65013
    • GSK Investigational Site
  • Toulon, France, 83000
    • GSK Investigational Site
  • Toulouse cedex 9, France, 31059
    • GSK Investigational Site
  • Tours cedex 9, France, 37044
    • GSK Investigational Site
  • Vieux Condé, France, 59690
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10367
    • GSK Investigational Site
  • Berlin, Germany, 14059
    • GSK Investigational Site
  • Berlin, Germany, 10117
    • GSK Investigational Site
  • Berlin, Germany, 13125
    • GSK Investigational Site
  • Berlin, Germany, 10787
    • GSK Investigational Site
  • Berlin, Germany, 13581
    • GSK Investigational Site
  • Hamburg, Germany, 22143
    • GSK Investigational Site
  • Hamburg, Germany, 20246
    • GSK Investigational Site
  • Hamburg, Germany, 20253
    • GSK Investigational Site
  • Bayern
    • Dillingen, Bayern, Germany, 89407
      • GSK Investigational Site
    • Kuenzing, Bayern, Germany, 94550
      • GSK Investigational Site
    • Muenchen, Bayern, Germany, 80809
      • GSK Investigational Site
    • Schwabach, Bayern, Germany, 91126
      • GSK Investigational Site
  • Hessen
    • Frankfurt, Hessen, Germany, 60596
      • GSK Investigational Site
    • Gelnhausen, Hessen, Germany, 63571
      • GSK Investigational Site
    • Neu-Isenburg, Hessen, Germany, 63263
      • GSK Investigational Site
    • Rodgau, Hessen, Germany, 63110
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Koeln, Nordrhein-Westfalen, Germany, 51069
      • GSK Investigational Site
  • Sachsen
    • Dresden, Sachsen, Germany, 01307
      • GSK Investigational Site
    • Leipzg, Sachsen, Germany, 04109
      • GSK Investigational Site
    • Leipzig, Sachsen, Germany, 04103
      • GSK Investigational Site
  • Sachsen-Anhalt
    • Magdeburg, Sachsen-Anhalt, Germany, 39112
      • GSK Investigational Site
  • Schleswig-Holstein
    • Geesthacht, Schleswig-Holstein, Germany, 21502
      • GSK Investigational Site
  • Thueringen
    • Schmoelln, Thueringen, Germany, 04626
      • GSK Investigational Site
• Hungary
  • Balassagyarmat, Hungary, 2660
    • GSK Investigational Site
  • Budapest, Hungary, 1529
    • GSK Investigational Site
  • Debrecen, Hungary, 4032
    • GSK Investigational Site
  • Deszk, Hungary, 6772
    • GSK Investigational Site
  • Farkasgyepű, Hungary, 8582
    • GSK Investigational Site
  • Gyöngyös, Hungary, 3200
    • GSK Investigational Site
  • Gödöllő, Hungary, 2100
    • GSK Investigational Site
  • Nyíregyháza, Hungary, 4400
    • GSK Investigational Site
  • Szikszó, Hungary, 3800
    • GSK Investigational Site
  • Szombathely, Hungary, 9700
    • GSK Investigational Site
  • Sátoraljaújhely, Hungary, 3980
    • GSK Investigational Site
  • Törökbálint, Hungary, 2045
    • GSK Investigational Site
• Japan
  • Aichi, Japan, 455-8530
    • GSK Investigational Site
  • Aichi, Japan, 457-8510
    • GSK Investigational Site
  • Aichi, Japan, 454-8502
    • GSK Investigational Site
  • Chiba, Japan, 296-8602
    • GSK Investigational Site
  • Fukuoka, Japan, 802-0052
    • GSK Investigational Site
  • Fukuoka, Japan, 814-0180
    • GSK Investigational Site
  • Fukuoka, Japan, 832-0059
    • GSK Investigational Site
  • Fukuoka, Japan, 811-3195
    • GSK Investigational Site
  • Hokkaido, Japan, 070-8644
    • GSK Investigational Site
  • Ibaraki, Japan, 319-1113
    • GSK Investigational Site
  • Kanagawa, Japan, 252-0001
    • GSK Investigational Site
  • Miyagi, Japan, 989-1253
    • GSK Investigational Site
  • Okayama, Japan, 714-0081
    • GSK Investigational Site
  • Osaka, Japan, 596-8501
    • GSK Investigational Site
  • Shizuoka, Japan, 434-8511
    • GSK Investigational Site
  • Tokyo, Japan, 171-0014
    • GSK Investigational Site
  • Tokyo, Japan, 204-8585
    • GSK Investigational Site
  • Tokyo, Japan, 194-0023
    • GSK Investigational Site
• Netherlands
  • Alkmaar, Netherlands, 1815 JD
    • GSK Investigational Site
  • Almelo, Netherlands, 7609 PP
    • GSK Investigational Site
  • Almere, Netherlands, 1311 RL
    • GSK Investigational Site
  • Beek, Netherlands, 6191 JW
    • GSK Investigational Site
  • EDE, Netherlands, 6716 RP
    • GSK Investigational Site
  • Eindhoven, Netherlands, 5623 EJ
    • GSK Investigational Site
  • Enschede, Netherlands, 7513 ER
    • GSK Investigational Site
  • Groningen, Netherlands, 9728 NP
    • GSK Investigational Site
  • Helmond, Netherlands, 5707 HA
    • GSK Investigational Site
  • Hoorn, Netherlands, 1624 NP
    • GSK Investigational Site
  • Tubbergen, Netherlands, 7651 JH
    • GSK Investigational Site
  • Veldhoven, Netherlands, 5504 DB
    • GSK Investigational Site
  • Zutphen, Netherlands, 7207 AE
    • GSK Investigational Site
• Norway
  • Bekkestua, Norway, 1319
    • GSK Investigational Site
  • Bergen, Norway, 5017
    • GSK Investigational Site
  • Bodø, Norway, 8005
    • GSK Investigational Site
  • Elverum, Norway, 2408
    • GSK Investigational Site
  • Kløfta, Norway, 2040
    • GSK Investigational Site
  • Skedsmokorset, Norway, N-2020
    • GSK Investigational Site
  • Stavanger, Norway, 4005
    • GSK Investigational Site
  • Trondheim, Norway, 7027
    • GSK Investigational Site
  • Trondheim, Norway, 7011
    • GSK Investigational Site
• Philippines
  • Cebu City, Philippines, 6000
    • GSK Investigational Site
  • Dasmariñas, Cavite, Philippines, 4114
    • GSK Investigational Site
  • Marikina City, Philippines, 1800
    • GSK Investigational Site
  • Marilao, Bulacan, Philippines, 3019
    • GSK Investigational Site
  • Quezon City, Philippines, 1109
    • GSK Investigational Site
• Slovakia
  • Bardejov, Slovakia, 085 01
    • GSK Investigational Site
  • Humenne, Slovakia, 066 01
    • GSK Investigational Site
  • Poprad, Slovakia, 058 01
    • GSK Investigational Site
  • Revuca, Slovakia, 050 01
    • GSK Investigational Site
  • Spisska Nova Ves, Slovakia, 052 01
    • GSK Investigational Site
  • Vrable, Slovakia, 952 01
    • GSK Investigational Site
• Sweden
  • Göteborg, Sweden, SE-413 45
    • GSK Investigational Site
  • Göteborg, Sweden, SE-412 63
    • GSK Investigational Site
  • Höllviken, Sweden, SE-236 32
    • GSK Investigational Site
  • Linköping, Sweden, SE-582 16
    • GSK Investigational Site
  • Luleå, Sweden, SE-971 89
    • GSK Investigational Site
  • Lund, Sweden, SE-221 85
    • GSK Investigational Site
  • Malmö, Sweden, SE-211 52
    • GSK Investigational Site
  • Stockholm, Sweden, SE-111 57
    • GSK Investigational Site
  • Stockholm, Sweden, SE-113 61
    • GSK Investigational Site
  • Vällingby, Sweden, SE-162 68
    • GSK Investigational Site
• Ukraine
  • Donetsk, Ukraine, 83099
    • GSK Investigational Site
  • Ivano-Frankivsk, Ukraine, 76018
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61124
    • GSK Investigational Site
  • Kharkiv, Ukraine, 61037
    • GSK Investigational Site
  • Kiev, Ukraine, 03680
    • GSK Investigational Site
  • Kyiv, Ukraine, 03680
    • GSK Investigational Site
  • Simferopol, Ukraine, 95043
    • GSK Investigational Site
  • Zaporizhia, Ukraine, 69035
    • GSK Investigational Site
• United States
  • Alabama
    • Jasper, Alabama, United States, 35501
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Investigational Site
  • California
    • Long Beach, California, United States, 90822
      • GSK Investigational Site
    • Los Angeles, California, United States, 90095
      • GSK Investigational Site
    • Palo Alto, California, United States, 94304
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • San Diego, California, United States, 92117
      • GSK Investigational Site
    • San Diego, California, United States, 92103-8415
      • GSK Investigational Site
    • Torrance, California, United States, 90502
      • GSK Investigational Site
  • Florida
    • Clearwater, Florida, United States, 33765
      • GSK Investigational Site
    • DeLand, Florida, United States, 32720
      • GSK Investigational Site
    • Orlando, Florida, United States, 32822
      • GSK Investigational Site
    • Panama City, Florida, United States, 32405
      • GSK Investigational Site
  • Kansas
    • Topeka, Kansas, United States, 66606
      • GSK Investigational Site
  • Michigan
    • Livonia, Michigan, United States, 48152
      • GSK Investigational Site
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • GSK Investigational Site
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • GSK Investigational Site
  • New Jersey
    • Cherry Hill, New Jersey, United States, 08003
      • GSK Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • GSK Investigational Site
    • Greenville, South Carolina, United States, 29615
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
    • Union, South Carolina, United States, 29379
      • GSK Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23225
      • 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:

• Diagnosis of COPD
• 10 pack-year or greater history of cigarette smoking
• Post-bronchodilator FEV1/FVC of <0.7
• Predicted FEV1 of 70% of normal or less
• Modified Medical Research Council (mMRC) dyspnea score of 2 or greater

Exclusion Criteria:

• Women who are pregnant, lactating, or planning to become pregnant
• Respiratory disorders other than COPD, including a current diagnosis of asthma
• Clinically significant non-respiratory diseases or abnormalities that are not adequately controlled
• Significant allergy or hypersensitivity to anticholinergics, beta2-agonists, or the excipients of magnesium stereate or lactose used in the inhaler delivery device
• Hospitalization for COPD or pneumonia within 12 weeks prior to screening
• Lung volume reduction surgery within 12 weeks prior to screening
• Abnormal and clinically significant ECG findings at screening
• Clinically significant laboratory findings at screening
• Use of systemic corticosteroids, antibiotics for respiratory tract infections, strong cytochrome P450 3A4 inhibitors, high dose inhaled steroids (>1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, ipratropium, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
• Use of long-term oxygen therapy (12 hours or greater per day)
• Regular use of nebulized treatment with short-acting bronchodilators
• Participation in the acute phase of a pulmonary rehabilitation program
• A know or suspected history of alcohol or drug abuse
• Affiliation with the investigational site
• Previous use of GSK573719 or GW642444 alone or in combination, including the combination of fluticasone furoate and GW642444

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo only; Placebo; Other Names: placebo
Experimental: GSK573719; 125mcg	Drug: GSK573719 125mcg; 125mcg; Other Names: umeclidinium bromide
Experimental: GW642444; 25mcg	Drug: GW642444 25mcg; 25mcg; Other Names: vilanterol trifenatate
Experimental: GSK573719/GW642444; 125/25mcg	Drug: GSK573719/GW642444 125/25mcg; 125/25mcg; Other Names: umeclidinium bromide/vilanterol trifenatate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24)	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is the mean of the FEV1 values obtained 23 and 24 hours after the morning dosing on Day 168). Change from Baseline at a particular visit was calculated as the trough FEV1 at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline , smoking status, center group, day, and day by Baseline and day by treatment interactions. ITT=Intent-to-Treat; par.=participants.	Baseline and Day 169

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Transition Dyspnea Index (TDI) Focal Score at Day 168 (Week 24)	Considered an 'other' endpoint by the FDA. The TDI is an interviewer-administered instrument which measures the changes in the participant's dyspnea from Baseline. This questionnaire was collected on Days 28, 84 and 168. The scores in the TDI evaluate ratings for 3 different categories (functional impairment, magnitude of task in exertional capacity, and magnitude of effort). TDI scores ranged from -3 (major deterioration) to +3 (major improvement); total score = -9 to 9. Analysis was performed using a repeated measures model with covariates of treatment, Baseline dyspnea index (BDI) focal score,smoking status, center group, day, day by BDI focal score and day by treatment interactions.	Day 168 (Week 24)
Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168	FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The WM FEV1 was derived by calculating the area under the FEV1/time curve (AUC) using the trapezoidal rule, and then dividing the value by the time interval over which the AUC was calculated. The WM was calculated at Days 1, 28, 84, and 168 using the 0-6-hour post-dose FEV1 measurements collected on that day, which included pre-dose (Day 1: 30 minutes [min] and 5 min prior to dosing; other serial visits: 23 and 24 hours after the previous morning dose) and post-dose at 15 min, 30 min, 1 hour, 3 hours, and 6 hours. Change from Baseline at a particular visit was calculated as the WM at that visit minus Baseline. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (mean of the two assessments made 30 min and 5 min pre-dose on Day 1), smoking status, center group, day, and day by Baseline and day by treatment interactions.	Baseline and Day 168

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Mean Shortness of Breath With Daily Activities (SOBDA) Score for Week 24	The newly developed SOBDA questionnaire assesses dyspnea or shortness of breath (SOB) with daily activities. The SOBDA questionnaire is made up of 13 items completed by the participant (par.) each evening prior to bedtime, when the par. is instructed to reflect on the current day's activities. The daily score is computed as the mean of the scores on the 13 items (>=7 items must have non-missing responses for this to be calculated). The par. is assigned a weekly mean SOBDA score ranging from 1 to 4 (greater scores indicate more severe breathlessness with daily activities) based on the mean of 7 days of data (>=4 of 7 days must be completed for a weekly mean to be calculated). Change from BL is the mean weekly SOBDA score minus BL. Analysis was performed using MMRM with covariates of treatment, BL (mean score in the week prior to treatment), smoking status, center group, week, week by BL and week by treatment interactions. This MMRM analysis only included Weeks 4, 8, 12, and 24.	Baseline and Week 24

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Celli B, Crater G, Kilbride S, Mehta R, Tabberer M, Kalberg CJ, Church A. Once-daily umeclidinium/vilanterol 125/25 mcg in COPD: a randomized, controlled study. Chest. 2014 May;145(5):981-991. doi: 10.1378/chest.13-1579. Erratum In: Chest. 2022 Jul;162(1):269.

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: March 1, 2011
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): April 19, 2012

Study Registration Dates

• First Submitted: March 10, 2011
• First Submitted That Met QC Criteria: March 11, 2011
• First Posted (Estimate): March 14, 2011

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: anticholinergic; long-acting beta agonist
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Anticonvulsants; Bromides
• Other Study ID Numbers: 113361; 2010-023348-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Study Data/Documents

1. Informed Consent Form
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Dataset Specification
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Individual Participant Data Set
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Study Protocol
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Annotated Case Report Form
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: 113361
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register