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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)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

125/25 mcg once-daily GSK573719/GW642444

125mcg once-daily GSK573719

Placebo once-daily

About this trial

This is an interventional other trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Obstructive Pulmonary Disease, COPD, nDPI, long-acting beta agonist, long-acting muscarinic antagonist, tolerability, safety

Eligibility Criteria

40 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

GSK573719/GW642444

GSK573719

Placebo

Arm Description

125/25 mcg once-daily

125 mcg once-daily

inactive

Outcomes

Primary Outcome Measures

Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)

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.

Secondary Outcome Measures

Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period

A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.

Time to the First On-treatment COPD Exacerbation

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.

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

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.

Change From Baseline in Albumin, Total Protein, and Hemoglobin at 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.

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

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.

Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at 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.

Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at 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.

Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at 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.

Change From Baseline in Hematocrit at 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.

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

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.

Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period

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.

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

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.

Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period

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.

Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline

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.

Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation

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.

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

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.

Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period

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.

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

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.

Full Information

NCT ID

NCT01316887

First Posted

March 15, 2011

Last Updated

April 30, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01316887

Brief Title

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)

Acronym

COPD nDPI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2011 (undefined)

Primary Completion Date

July 1, 2012 (Actual)

Study Completion Date

July 21, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease, COPD, nDPI, long-acting beta agonist, long-acting muscarinic antagonist, tolerability, safety

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

563 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GSK573719/GW642444

Arm Type

Experimental

Arm Description

125/25 mcg once-daily

Arm Title

GSK573719

Arm Type

Experimental

Arm Description

125 mcg once-daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

inactive

Intervention Type

Drug

Intervention Name(s)

125/25 mcg once-daily GSK573719/GW642444

Intervention Description

GSK573719/GW642444

Intervention Type

Drug

Intervention Name(s)

125mcg once-daily GSK573719

Intervention Description

GSK573719

Intervention Type

Drug

Intervention Name(s)

Placebo once-daily

Intervention Description

inactive

Primary Outcome Measure Information:

Title

Number of Participants With Any On-treatment Adverse Event (AE) or Any Serious Adverse Event (SAE)

Description

Time Frame

From the start of study drug up to 52 weeks

Secondary Outcome Measure Information:

Title

Number of Participants With at Least One Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Over the Course of the 52-week Treatment Period

Description

A COPD exacerbation is defined as worsening symptoms of COPD requiring a systemic corticosteroid, an antibiotic, and/or hospitalization.

Time Frame

From the start of study drug up to 52 weeks

Title

Time to the First On-treatment COPD Exacerbation

Description

Time Frame

From the start of study drug up to 52 weeks

Title

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

Change From Baseline in Albumin, Total Protein, and Hemoglobin at Months 3, 6, 9, and 12

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

Change From Baseline in Creatinine, Direct Bilirubin, Indirect Bilirubin, Total Bilirubin, and Uric Acid at Months 3, 6, 9, and 12

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

Change From Baseline in the Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Segmented Neutrophils in Blood at Months 3, 6, 9, and 12

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

Change From Baseline in Eosinophil Count, Platelet Count, and White Blood Cell (WBC) Count at Months 3, 6, 9, and 12

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

Change From Baseline in Hematocrit at Months 3, 6, 9, and 12

Description

Time Frame

Baseline; Months 3, 6, 9, and 12

Title

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

Description

Time Frame

Baseline; from the start of study drug up to 52 weeks

Title

Maximum Change From Baseline in Pulse Rate Over the Course of the 52-week Treatment Period

Description

Time Frame

Baseline; from the start of study drug up to 52 weeks

Title

Description

Time Frame

Baseline; from the start of study drug up to 52 weeks

Title

Maximum Change From Baseline in the ECG Parameter of Heart Rate Over the Course of the 52-week Treatment Period

Description

Time Frame

Baseline; from the start of study drug up to 52 weeks

Title

Number of Participants With the Indicated ECG Result Interpretations at Any Time Post-Baseline

Description

Time Frame

From the start of study drug up to 52 weeks

Title

Number of Participants With the Indicated Change From Screening to Any Time Post-Baseline in Holter ECG Interpretation

Description

Time Frame

Screening; from the start of study drug up to 52 weeks

Title

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

Description

Time Frame

Baseline; from the start of study drug up to 52 weeks

Title

Change From Baseline in the Percentage of Rescue-free Days Over the Course of the 52-week Treatment Period

Description

Time Frame

From the start of study drug up to 52 weeks

Title

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

Description

Time Frame

Baseline; Months 1, 3, 6, 9, and 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

GSK Clinical Trials

Organizational Affiliation

GlaxoSmithKline

Official's Role

Study Director

Facility Information:

Facility Name

GSK Investigational Site

City

Mobile

State/Province

Alabama

ZIP/Postal Code

36608

Country

United States

Facility Name

GSK Investigational Site

City

Sunset

State/Province

Louisiana

ZIP/Postal Code

70584

Country

United States

Facility Name

GSK Investigational Site

City

Plymouth

State/Province

Minnesota

ZIP/Postal Code

55441

Country

United States

Facility Name

GSK Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

GSK Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

GSK Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

GSK Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

GSK Investigational Site

City

Erie

State/Province

Pennsylvania

ZIP/Postal Code

16508

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406-7108

Country

United States

Facility Name

GSK Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

GSK Investigational Site

City

Union

State/Province

South Carolina

ZIP/Postal Code

29379

Country

United States

Facility Name

GSK Investigational Site

City

Corsicana

State/Province

Texas

ZIP/Postal Code

75110

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23229

Country

United States

Facility Name

GSK Investigational Site

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26505

Country

United States

Facility Name

GSK Investigational Site

City

Puente Alto - Santiago

State/Province

Región Metro De Santiago

ZIP/Postal Code

8207257

Country

Chile

Facility Name

GSK Investigational Site

City

Talca

State/Province

Región Metro De Santiago

ZIP/Postal Code

3460001

Country

Chile

Facility Name

GSK Investigational Site

City

Santiago

ZIP/Postal Code

8380453

Country

Chile

Facility Name

GSK Investigational Site

City

Bacau

ZIP/Postal Code

600252

Country

Romania

Facility Name

GSK Investigational Site

City

Brasov

ZIP/Postal Code

500112

Country

Romania

Facility Name

GSK Investigational Site

City

Brasov

ZIP/Postal Code

500283

Country

Romania

Facility Name

GSK Investigational Site

City

Bucuresti

ZIP/Postal Code

70000

Country

Romania

Facility Name

GSK Investigational Site

City

Pitesti

ZIP/Postal Code

110084

Country

Romania

Facility Name

GSK Investigational Site

City

Ploiesti

ZIP/Postal Code

100172

Country

Romania

Facility Name

GSK Investigational Site

City

Ploiesti

ZIP/Postal Code

100379

Country

Romania

Facility Name

GSK Investigational Site

City

Timisoara

ZIP/Postal Code

300310

Country

Romania

Facility Name

GSK Investigational Site

City

Ekaterinburg

ZIP/Postal Code

620109

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Ivanovo

ZIP/Postal Code

153005

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

119 048

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Moscow

ZIP/Postal Code

127018

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Novgorod

ZIP/Postal Code

173008

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Penza

ZIP/Postal Code

440067

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

193231

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Saint-Petersburg

ZIP/Postal Code

194354

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Shakhty, Rostov Region

ZIP/Postal Code

346510

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Sochi

ZIP/Postal Code

354057

Country

Russian Federation

Facility Name

GSK Investigational Site

City

St'Petersburg

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tomsk

ZIP/Postal Code

634 050

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Tumen

ZIP/Postal Code

625023

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Vladivostok

ZIP/Postal Code

690950

Country

Russian Federation

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

826 06

Country

Slovakia

Facility Name

GSK Investigational Site

City

Bratislava

ZIP/Postal Code

841 08

Country

Slovakia

Facility Name

GSK Investigational Site

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Povazska Bystrica

ZIP/Postal Code

017 26

Country

Slovakia

Facility Name

GSK Investigational Site

City

Sala

ZIP/Postal Code

927 01

Country

Slovakia

Facility Name

GSK Investigational Site

City

Zilina

ZIP/Postal Code

012 07

Country

Slovakia

Facility Name

GSK Investigational Site

City

Benoni

State/Province

Gauteng

ZIP/Postal Code

1501

Country

South Africa

Facility Name

GSK Investigational Site

City

Bellville

ZIP/Postal Code

7530

Country

South Africa

Facility Name

GSK Investigational Site

City

Bloemfontein

ZIP/Postal Code

9301

Country

South Africa

Facility Name

GSK Investigational Site

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

GSK Investigational Site

City

Gatesville

ZIP/Postal Code

7764

Country

South Africa

Facility Name

GSK Investigational Site

City

Mowbray

ZIP/Postal Code

7700

Country

South Africa

Facility Name

GSK Investigational Site

City

Somerset West

ZIP/Postal Code

7130

Country

South Africa

Facility Name

GSK Investigational Site

City

Tygerberg

ZIP/Postal Code

7505

Country

South Africa

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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.

Links:

URL

https://www.clinicalstudydatarequest.com

Description

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

Available IPD and Supporting Information:

Available IPD/Information Type

Statistical Analysis Plan

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Dataset Specification

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Clinical Study Report

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

113359

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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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)

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial