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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 285
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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)
- •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
Arms & Interventions
GSK573719 125mcg
125mcg once-daily via novel dry powder inhaler
Intervention: GSK573719 125mcg (Drug)
GSK573719 250mcg
250mcg once-daily via novel dry powder inhaler
Intervention: GSK573719 250mcg (Drug)
GSK573719 500mcg
500mcg once-daily via novel dry powder inhaler
Intervention: GSK573719 500mcg (Drug)
Placebo
once-daily via novel dry powder inhaler
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) at Day 29
Time Frame: Baseline and 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 Outcomes
- Change From Baseline in Serial FEV1 Over 24 Hours After Dosing at Day 1 and Day 28(Baseline, Day 1, and Day 28)
- 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)