A 52-Week, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 and GSK573719 in Subjects With Chronic Obstructive Pulmonary Disease (COPD) (COPD nDPI)

April 30, 2018 updated by: GlaxoSmithKline

A 52 Week Study to Evaluate the Safety and Tolerability of GSK573719/GW642444 125mcg Once-daily Alone and in Combination With GW642444 25mcg Once-daily Via Novel Dry Powder Inhaler (nDPI) in Subjects With Chronic Obstructive Pulmonary Disease

The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Several studies have demonstrated the efficacy and safety of combining an individual LABA compound plus an individual LAMA compound in COPD. These studies have shown the combination of these two products to be superior to either agent alone on a variety of outcomes in COPD. The beneficial effects of this combination regimen are likely due to the different mechanisms of action of the two bronchodilators (smooth bronchial muscle relaxation from activation of beta2 receptors from the LABA product and inhibition of acetylcholine-mediated smooth bronchial muscle contraction via blockade of muscarinic receptors from the LAMA product). The availability of a LABA/LAMA combination in one product instead of two individual products is a technical and therapeutic advancement in the pharmacological armamentarium for COPD and may lead to increased patient compliance due to once-daily administration. The purpose of this 52-week study is to evaluate the long-term safety (in terms of adverse events, COPD exacerbations, laboratory, ECG, and Holter findings, vital signs, use of rescue medication, and lung function) of GSK573719/GW642444 Inhalation Powder 125/25mcg in subjects with COPD. The long-term safety of GSK573719 Inhalation Powder 125mcg will also be evaluated. A placebo arm is included to evaluate these products compared to an inactive control. All treatments will be delivered once-daily via the nDPI. This study will establish the long-term safety profile of GSK573719/GW642444 Inhalation Powder 125/25mcg once-daily in subjects with COPD. The safety profile of GSK573719 Inhalation Powder125mcg once-daily will also be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
563

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Chile
      • Santiago, Chile, 8380453
        • GSK Investigational Site
    • Región Metro De Santiago
      • Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
        • GSK Investigational Site
      • Talca, Región Metro De Santiago, Chile, 3460001
        • GSK Investigational Site
  • Romania
      • Bacau, Romania, 600252
        • GSK Investigational Site
      • Brasov, Romania, 500283
        • GSK Investigational Site
      • Brasov, Romania, 500112
        • GSK Investigational Site
      • Bucuresti, Romania, 70000
        • GSK Investigational Site
      • Pitesti, Romania, 110084
        • GSK Investigational Site
      • Ploiesti, Romania, 100172
        • GSK Investigational Site
      • Ploiesti, Romania, 100379
        • GSK Investigational Site
      • Timisoara, Romania, 300310
        • GSK Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620109
        • GSK Investigational Site
      • Ivanovo, Russian Federation, 153005
        • GSK Investigational Site
      • Moscow, Russian Federation, 127018
        • GSK Investigational Site
      • Moscow, Russian Federation, 119 048
        • GSK Investigational Site
      • Novgorod, Russian Federation, 173008
        • GSK Investigational Site
      • Penza, Russian Federation, 440067
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 194354
        • GSK Investigational Site
      • Saint-Petersburg, Russian Federation, 193231
        • GSK Investigational Site
      • Shakhty, Rostov Region, Russian Federation, 346510
        • GSK Investigational Site
      • Sochi, Russian Federation, 354057
        • GSK Investigational Site
      • St'Petersburg, Russian Federation, 197706
        • GSK Investigational Site
      • Tomsk, Russian Federation, 634 050
        • GSK Investigational Site
      • Tumen, Russian Federation, 625023
        • GSK Investigational Site
      • Vladivostok, Russian Federation, 690950
        • GSK Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 826 06
        • GSK Investigational Site
      • Bratislava, Slovakia, 841 08
        • GSK Investigational Site
      • Poprad, Slovakia, 058 01
        • GSK Investigational Site
      • Povazska Bystrica, Slovakia, 017 26
        • GSK Investigational Site
      • Sala, Slovakia, 927 01
        • GSK Investigational Site
      • Zilina, Slovakia, 012 07
        • GSK Investigational Site
  • South Africa
      • Bellville, South Africa, 7530
        • GSK Investigational Site
      • Bloemfontein, South Africa, 9301
        • GSK Investigational Site
      • Durban, South Africa, 4001
        • GSK Investigational Site
      • Gatesville, South Africa, 7764
        • GSK Investigational Site
      • Mowbray, South Africa, 7700
        • GSK Investigational Site
      • Somerset West, South Africa, 7130
        • GSK Investigational Site
      • Tygerberg, South Africa, 7505
        • GSK Investigational Site
    • Gauteng
      • Benoni, Gauteng, South Africa, 1501
        • GSK Investigational Site
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • GSK Investigational Site
    • Louisiana
      • Sunset, Louisiana, United States, 70584
        • GSK Investigational Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55441
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • GSK Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • GSK Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43215
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16508
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29406-7108
        • GSK Investigational Site
      • Spartanburg, South Carolina, United States, 29303
        • GSK Investigational Site
      • Union, South Carolina, United States, 29379
        • GSK Investigational Site
    • Texas
      • Corsicana, Texas, United States, 75110
        • GSK Investigational Site
      • San Antonio, Texas, United States, 78229
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • outpatient
  • signed and dated written informed consent
  • 40 years of age or older
  • male and female subjects
  • COPD diagnosis
  • at least 10 pack-year smoking history
  • post-albuterol/salbutamol FEV1/FVC ratio of <0.70 and post-albuterol/salbutamol FEV1 greater than or equal to 35% and less than or equal to 80% of predicted normal

Exclusion Criteria:

  • Pregant or lactating women or women planning to become pregnant during the study
  • current diagnosis of asthma
  • other respiratory disorders other than COPD
  • other diseases/abnormalities that are uncontrolled including cancer not in remission for at least 5 years
  • chest x-ray or CT scan with clinically significant abnormalities not believed to be due to COPD
  • hypersensitivity to anticholinergics, beta-agonists, lactose/milk protein or magnesium stearate or medical conditions associated with inhaled anticholinergics
  • hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1
  • lung volume reduction surgery within 12 months prior to Visit 1
  • abnormal and clinically significant ECG at Visit 1
  • abnormal and clinically significant Holter monitor finding at Visit 1
  • significantly abnormal finding from laboratory tests at Visit 1
  • unable to withhold albuterol/salbutamol and/or ipratropium bromide at least 4 hours prior to spirometry at each visit
  • use of depot corticosteroids within 12 weeks of Visit 1
  • use of oral or parenteral corticosteroids within 6 weeks of Visit 1
  • use of anitbiotics for lower respiratory tract infection within 6 weeks of Visit 1
  • use of cytochrome P450 3A4 inhibitors within 6 weeks of Visit 1
  • us of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) products if LABA/ICS therapy is discontinued completely within 30 days of Visit 1
  • use of ICS at a dose of >10000mcg/day of fluticasone propionate or equivalent within 30 days of Visit 1
  • initiation or discontinuation of ICS within 30 days of Visit 1
  • use of tiotropium within 14 days of Visit 1
  • use of roflumilast within 14 days of Visit 1
  • use of theophyllines within 48 hours of Visit 1
  • use of oral leukotriene inhibitors within 48 hours prior to Visit 1
  • use of long-acting oral beta-agonists within 48 hours of Visit 1
  • use of short-acting oral beta-agonists within 12 hours of Visit 1
  • use of inhaled long-acting beta-agonists within 48 hours prior to Visit 1
  • use of LABA/ICS combination products only if discontinuing LABA therapy and switching to ICS monotherapy within 48 hours of Visit 1 for the LABA component
  • use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1
  • use of inhaled short acting beta-agonists within 4 hours of Visit 1
  • use of inhaled short-acting anticholinergics within 4 hours of Visit 1
  • use of inhaled short-acting anticholinergic/short-acting beta2-agonist combination products within 4 hours of Visit 1
  • use of any other investigational medication within 30 days or 5 drug half-lives (whichever is longer) of Visit 1
  • long-term oxygen therapy prescribed for >12 hours per day
  • regular use of short-acting bronchodilators
  • use of CPAP or NIPPV
  • participation in the maintenance phase of a pulmonary rehabilitation program
  • known or suspected history of alcohol or drug abluse with 2 years prior to Visit 1
  • anyone affiliated with the investigator site (e.g., investigator, study coordinator, etc.)
  • previous use of GSK573719, GW642444 , GSK573719/GW642444 combination, GSK233705/GW642444 combination, or Fluticasone Furoate/GW642444 combination

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: GSK573719
125 mcg once-daily
Drug: 125mcg once-daily GSK573719
GSK573719
Experimental: GSK573719/GW642444
125/25 mcg once-daily
Drug: 125/25 mcg once-daily GSK573719/GW642444
GSK573719/GW642444
Placebo Comparator: Placebo
inactive
Drug: Placebo once-daily
inactive

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)
Time Frame: From the start of study drug up to 52 weeks
An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is an event of possible drug-induced liver injury with hyperbilirubinaemia. Medical or scientific judgment was to have been exercised in other important medical events. AEs with an onset on or after the date of the first dose of study drug and up to 1 day after the date of the last recorded dose of study drug were considered to be on-treatment AEs, Refer to the general AE/SAE module for a complete list of AEs and SAEs.
From the start of study drug up to 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period
Time Frame: From the start of study drug up to 52 weeks
A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.
From the start of study drug up to 52 weeks
Time to the First On-treatment COPD Exacerbation
Time Frame: From the start of study drug up to 52 weeks
An on-treatment COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization at any time during the 52-week Treatment Period. The time to the first on-treatment exacerbation was calculated as the exacerbation onset date of the first on-treatment exacerbation minus the date of the start of treatment + 1. The median time to the first on-treatment exacerbation was derived from the Kaplan-Meier analysis. A participant who did not experience an exacerbation prior to completing the study or withdrawal is considered censored; a time to first COPD exacerbation cannot be calculated for these participants.
From the start of study drug up to 52 weeks
Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Gamma Glutamyl Transferase (GGT) at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of ALT, ALP, AST, CK, and GGT at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of albumin, total protein, and hemoglobin at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Calcium, Carbon Dioxide (CO2) Content/Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of calcium, CO2 content/bicarbonate, chloride, glucose, IP, potassium, sodium, and urea/BUN at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of creatinine, direct bilirubin, indirect bilirubin, total bilirubin, and uric acid at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of the percentage of basophils, eosinophils, lymphocytes, monocytes, and segmented neutrophils at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of eosinophils, platelets, and WBC count at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline in Hematocrit at Months 3, 6, 9, and 12
Time Frame: Baseline; Months 3, 6, 9, and 12
Blood samples were collected for the measurement of hematocrit at Baseline and Months 3, 6, 9, and 12. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The value defined as the "Baseline" value is the most recent value collected prior to the start of treatment. For most participants, the Baseline value is the value collected at the Screening visit; however, for some participants, the Baseline value may have been collected at an unscheduled visit.
Baseline; Months 3, 6, 9, and 12
Change From Baseline to Maximum Systolic Blood Pressure (SBP) and Change From Baseline to Minimum Diastolic Blood Pressure (DBP) Over the Course of the 52-week Treatment Period
Time Frame: Baseline; from the start of study drug up to 52 weeks
Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for SBP and the minimum post-Basline value for DBP were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; from the start of study drug up to 52 weeks
Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period
Time Frame: Baseline; from the start of study drug up to 52 weeks
Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for pulse rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; from the start of study drug up to 52 weeks
Maximum Change From Baseline in the Electrocardiogram (ECG) Parameters of QT Interval Corrected for Heart Rate by Bazett's Formula (QTcB), QT Interval Corrected for Heart Rate by Fridericia's Formula (QTcF), and PR Interval Over the Course of the 52-week
Time Frame: Baseline; from the start of study drug up to 52 weeks
12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline values for QTcF, QTcB, and PR interval were derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; from the start of study drug up to 52 weeks
Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period
Time Frame: Baseline; from the start of study drug up to 52 weeks
12-lead ECG measurements were obtained. Baseline is defined as the most recent recorded value before dosing on Day 1. The maximum post-Baseline value for heart rate was derived using any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Baseline; from the start of study drug up to 52 weeks
Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline
Time Frame: From the start of study drug up to 52 weeks
Post-Baseline visits include scheduled, unscheduled, and Early Withdrawal visits. Only the worst-case interpretation was counted for each participant. Clinical significance and abnormal/normal findings are based on the assessment of the independent cardiologists.
From the start of study drug up to 52 weeks
Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation
Time Frame: Screening; from the start of study drug up to 52 weeks
Twenty-four hour Holter monitor (12-lead) evaluations were obtained. Holter Baseline values were those recorded at Screening. An "any time post-Baseline" Holter evaluation was derived as the worst evaluation recorded at any scheduled, unscheduled, or early withdrawal visit made after the start of study treatment. Change from Screening was calculated as the post-Screening value minus the Screening value. The order of severity for change from Screening Holter evaluation from worst to best is: clinically significant change: unfavorable; no change or insignificant change; clinically significant change: favorable, unable to compare, based on the assessment of the independent cardiologists.
Screening; from the start of study drug up to 52 weeks
Change From Baseline in the Mean Number of Puffs of Rescue Medication (Salbutamol and/or Ipratropium Bromide) Per Day Over the Course of the 52-week Treatment Period
Time Frame: Baseline; from the start of study drug up to 52 weeks
Participants recorded the number of puffs and/or the number of nebules of rescue albuterol/salbutamol and/or ipratropium bromide used in the past 24 hours for the relief of COPD symptoms in the daily diary. The total puffs of rescue medication for each day was calculated as follows: (number of salbutamol puffs + number of ipratropium puffs + [2 * number of salbutamol nebules] + [2 * number of ipratropium nebules]). Baseline is the mean during the week prior to Day 1. Change from Baseline was calculated as the mean number of puffs/day over Weeks 1-52 minus the mean number of puffs/day at Baseline. Analysis was performed using an Analysis of Covariance (ANCOVA) model with covariates of treatment, Baseline (mean during the week prior to Day 1), smoking status, and center group.
Baseline; from the start of study drug up to 52 weeks
Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period
Time Frame: From the start of study drug up to 52 weeks
Rescue-free days are defined as days on which albuterol/salbutamol and/or ipratropium bromide was not used. Baseline is the percentage during the week prior to Day 1. Change from Baseline was calculated as the mean percentage of rescue-free days over Weeks 1-52 minus the mean percentage of rescue-free days at Baseline.
From the start of study drug up to 52 weeks
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) at Months 1, 3, 6, 9, and 12
Time Frame: Baseline; Months 1, 3, 6, 9, and 12
FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FEV1 and FVC were the values obtained approximately 24 hours after the previous morning's dose of study medication. Baseline is the value recorded pre-dose on Day 1. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Analysis was performed using a repeated measures model with covariates of treatment, Baseline (assessment made immediately pre-dose on Day 1), smoking status, center group, month, and month by Baseline and month by treatment interactions.
Baseline; Months 1, 3, 6, 9, and 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 113359

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. Statistical Analysis Plan
    Information identifier: 113359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Study Protocol
    Information identifier: 113359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individual Participant Data Set
    Information identifier: 113359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 113359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 113359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Annotated Case Report Form
    Information identifier: 113359
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: 113359
    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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