28-day Repeat Dose Study of GSK573719
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
1 other identifier
interventional
285
4 countries
20
Brief Summary
The study will evaluate the efficacy, safety, and pharmacokinetics of GSK573719 compared with placebo in subjects with COPD
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2009
Shorter than P25 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedStudy Start
First participant enrolled
December 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
July 4, 2010
CompletedResults Posted
Study results publicly available
February 24, 2014
CompletedMarch 9, 2018
February 1, 2018
7 months
December 10, 2009
January 9, 2014
February 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline and Day 29
Secondary Outcomes (2)
Change From Baseline in Weighted Mean 0-6 Hour FEV1 Obtained Post-dose at Day 1 and Day 28
Baseline, Day 1, and Day 28
Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28
Baseline, Day 1, and Day 28
Study Arms (4)
GSK573719 125mcg
EXPERIMENTAL125mcg once-daily via novel dry powder inhaler
GSK573719 250mcg
EXPERIMENTAL250mcg once-daily via novel dry powder inhaler
GSK573719 500mcg
EXPERIMENTAL500mcg once-daily via novel dry powder inhaler
Placebo
PLACEBO COMPARATORonce-daily via novel dry powder inhaler
Interventions
Eligibility Criteria
You may qualify if:
- A signed and dated written informed consent prior to study participation
- Males or females of non-childbearing potential
- to 80 years of age
- COPD diagnosis
- 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
You may not qualify if:
- 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
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (20)
GSK Investigational Site
Madisonville, Kentucky, 42431, United States
GSK Investigational Site
Charlotte, North Carolina, 28207, United States
GSK Investigational Site
Spartanburg, South Carolina, 29303, United States
GSK Investigational Site
Union, South Carolina, 29379, United States
GSK Investigational Site
Tallinn, 10138, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tallinn, 13619, Estonia
GSK Investigational Site
Tartu, 51014, Estonia
GSK Investigational Site
Wiesbaden, Hesse, 65187, Germany
GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, 19055, Germany
GSK Investigational Site
Großhansdorf, Schleswig-Holstein, 22927, Germany
GSK Investigational Site
Berlin, 10787, Germany
GSK Investigational Site
Berlin, 13125, Germany
GSK Investigational Site
Berlin, 14057, Germany
GSK Investigational Site
Hamburg, 20253, Germany
GSK Investigational Site
Bialystok, 15-027, Poland
GSK Investigational Site
Bialystok, Poland
GSK Investigational Site
Gidle, 97-540, Poland
GSK Investigational Site
Krakow, 31-023, Poland
GSK Investigational Site
Lublin, 20-637, Poland
Related Publications (1)
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.
PMID: 23026438BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2009
First Posted
December 14, 2009
Study Start
December 15, 2009
Primary Completion
July 4, 2010
Study Completion
July 4, 2010
Last Updated
March 9, 2018
Results First Posted
February 24, 2014
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.