Back to results28-day Repeat Dose Study of GSK573719
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK573719 125mcg
GSK573719 250mcg
GSK573719 500mcg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Chronic Bronchitis, Anticholinergic, Emphysema, Long-acting muscarinic antagonist, COPD
Eligibility Criteria
Inclusion Criteria:
- A signed and dated written informed consent prior to study participation
- Males or females of non-childbearing potential
- 40 to 80 years of age
- COPD diagnosis
- 10 pack-years history or greater of cigarette smoking
- Post-bronchodilator FEV1/FVC ratio of 0.70 or less
- Post-bronchodilator FEV1 of 25 to 70% of predicted normal
Exclusion Criteria:
- Asthma
- Other significant respiratory disorders besides COPD, including alpha-1 deficiency
- Previous lung resection surgery
- Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
- Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
- Hospitalization for COPD or pneumonia within 3 months of screening
- Any significant disease that would put subject at risk through study participation
- BMI greater than 35
- Pacemaker
- Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
- Cancer
- Allergy or hypersensitivity to anticholinergics or inhaler excipients
- Diseases that would contraindicate the use of anticholinergics
- Use of oral corticosteroids within 6 weeks of screening
- Use of long-acting beta-agonists within 48 hours of screening
- Use of tiotropium within 14 days of screening
- Use of theophyllines or anti-leukotrienes within 48 hours of screening
- Use of short-acting bronchodilators within 4 to 6 hours of screening
- Use of investigational medicines within 30 days of screening
- Use of high dose inhaled corticosteroids
- Use of long-term oxygen therapy, CPAP or NIPPV
- Participation in acute phase of pulmonary rehabilitation program
- History of alcohol or drug abuse within 2 years prior to screening
- History of psychiatric disease limiting validity of consent
- Affiliation with the investigative site
- Previous use of GSK573719
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
GSK573719 125mcg
GSK573719 250mcg
GSK573719 500mcg
Placebo
Arm Description
125mcg once-daily via novel dry powder inhaler
250mcg once-daily via novel dry powder inhaler
500mcg once-daily via novel dry powder inhaler
once-daily via novel dry powder inhaler
Outcomes
Primary Outcome Measures
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
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 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Secondary Outcome Measures
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
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 weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01030965
Brief Title
28-day Repeat Dose Study of GSK573719
Official Title
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of GSK573719 Delivered Once-daily Over 28 Days in Subjects With COPD
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 15, 2009 (Actual)
Primary Completion Date
July 4, 2010 (Actual)
Study Completion Date
July 4, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD
Detailed Description
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate 3 doses of GSK573719 administered once-daily over 28 days in subjects with COPD.
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 Bronchitis, Anticholinergic, Emphysema, Long-acting muscarinic antagonist, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
285 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK573719 125mcg
Arm Type
Experimental
Arm Description
125mcg once-daily via novel dry powder inhaler
Arm Title
GSK573719 250mcg
Arm Type
Experimental
Arm Description
250mcg once-daily via novel dry powder inhaler
Arm Title
GSK573719 500mcg
Arm Type
Experimental
Arm Description
500mcg once-daily via novel dry powder inhaler
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
once-daily via novel dry powder inhaler
Intervention Type
Drug
Intervention Name(s)
GSK573719 125mcg
Intervention Description
125mcg once-daily
Intervention Type
Drug
Intervention Name(s)
GSK573719 250mcg
Intervention Description
250mcg once-daily
Intervention Type
Drug
Intervention Name(s)
GSK573719 500mcg
Intervention Description
500mcg once-daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
once-daily
Primary Outcome Measure Information:
Title
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
Description
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 on Treatment Day 29 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after dosing on Day 28. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between trough on Day 29 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline (BL), country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Time Frame
Baseline and Day 29
Secondary Outcome Measure Information:
Title
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
Description
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 weighted mean FEV1 was derived by calculating the area under the FEV1/time curve (AUC), and then dividing the value by the time interval over which the AUC was calculated. The weighted mean was calculated using the 0-6 hour post-dose measurements at Days 1 and 28, which included pre-dose (30 minutes prior to dosing on Day 1, or 24 hours after the previous day's dose on Day 28), and post-dose at 15 minutes, 30 minutes, 1 hour, 3 hours, and 6 hours. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between weighted mean at Days 1 and 28 and Baseline. Analysis was performed using a repeated measures model with covariates of Baseline, country, sex, age, treatment, smoking status, day, day by Baseline interaction, and day by treatment interaction.
Time Frame
Baseline, Day 1, and Day 28
Title
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Description
Serial spirometry assessments were conducted on Day 1 and Day 28 over the course of 24 hours and were obtained 0 (Day 28 only), 1, 3, 6, 23, and 24 hours after dosing. Baseline is defined as the mean of the FEV1 values obtained at 30 minutes and immediately pre-dose on Day 1. Change from Baseline is defined as the difference between FEV1 on Days 1 and 28 and Baseline.
Time Frame
Baseline, Day 1, and Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
A signed and dated written informed consent prior to study participation
Males or females of non-childbearing potential
40 to 80 years of age
COPD diagnosis
10 pack-years history or greater of cigarette smoking
Post-bronchodilator FEV1/FVC ratio of 0.70 or less
Post-bronchodilator FEV1 of 25 to 70% of predicted normal
Exclusion Criteria:
Asthma
Other significant respiratory disorders besides COPD, including alpha-1 deficiency
Previous lung resection surgery
Chest X-ray or CP scan showing clinically significant abnormalities not due to COPD
Use of oral steroids or antibiotics for a COPD exacerbation within 6 weeks of screening
Hospitalization for COPD or pneumonia within 3 months of screening
Any significant disease that would put subject at risk through study participation
BMI greater than 35
Pacemaker
Significantly abnormal ECG or clinical lab finding (including Hepatitis B or C)
Cancer
Allergy or hypersensitivity to anticholinergics or inhaler excipients
Diseases that would contraindicate the use of anticholinergics
Use of oral corticosteroids within 6 weeks of screening
Use of long-acting beta-agonists within 48 hours of screening
Use of tiotropium within 14 days of screening
Use of theophyllines or anti-leukotrienes within 48 hours of screening
Use of short-acting bronchodilators within 4 to 6 hours of screening
Use of investigational medicines within 30 days of screening
Use of high dose inhaled corticosteroids
Use of long-term oxygen therapy, CPAP or NIPPV
Participation in acute phase of pulmonary rehabilitation program
History of alcohol or drug abuse within 2 years prior to screening
History of psychiatric disease limiting validity of consent
Affiliation with the investigative site
Previous use of GSK573719
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
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
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
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
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
GSK Investigational Site
City
Tallinn
ZIP/Postal Code
13619
Country
Estonia
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65187
Country
Germany
Facility Name
GSK Investigational Site
City
Schwerin
State/Province
Mecklenburg-Vorpommern
ZIP/Postal Code
19055
Country
Germany
Facility Name
GSK Investigational Site
City
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10787
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
GSK Investigational Site
City
Bialystok
Country
Poland
Facility Name
GSK Investigational Site
City
Gidle
ZIP/Postal Code
97-540
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-023
Country
Poland
Facility Name
GSK Investigational Site
City
Lublin
ZIP/Postal Code
20-637
Country
Poland
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.
Citations:
PubMed Identifier
23026438
Citation
Decramer M, Maltais F, Feldman G, Brooks J, Harris S, Mehta R, Crater G. Bronchodilation of umeclidinium, a new long-acting muscarinic antagonist, in COPD patients. Respir Physiol Neurobiol. 2013 Jan 15;185(2):393-9. doi: 10.1016/j.resp.2012.08.022. Epub 2012 Sep 28.
Results Reference
background
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113589
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
113589
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
113589
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113589
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
113589
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
113589
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
113589
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
28-day Repeat Dose Study of GSK573719
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