Phase 3
Completed N=206
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01387230 ↗
Enrolled (actual)
206
Serious AEs
1.9%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 — -0.007; 0.120; 0.145 Liters — p=<0.001
Summary
The purpose of this study is to assess if 12 weeks' treatment with GSK573719 Inhalation Powder is safe and effective compared with placebo or no active drug intake, when administered once-daily in subjects with Chronic Obstructive Pulmonary Disease (COPD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 85 |
-0.007; 0.120; 0.145 | <0.001 sig |
| SECONDARY Change From Baseline in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Days 1, 28 (Week 4) and 84 (Week 12) |
0.017; 0.141; 0.164; -0.024; 0.141; 0.172 | — |
| SECONDARY Change From Baseline in Serial FEV1 Over 24 Hours Post-dose at Days 1 and 84 (Week 12) |
-0.001; 0.132; 0.142; 0.035; 0.165; 0.210 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD
- 10 pack-year or greater history of cigarette smoking
- Post-bronchodilator FEV1/FVC of 1000mcg fluticasone propionate or equivalent), PDE4 inhibitors, tiotropium, oral beta2-agoinists, short- and long-acting inhaled beta2-agonists, inhaled sodium cromoglycate or nedocromil sodium, or investigational medicines for defined time periods prior to the screening visit
- Use of long-term oxygen therapy (12 hours or greater per day)
- Regular use of nebulized treatment with short-acting bronchodilators
- Participation in the acute phase of a pulmonary rehabilitation program
- A know or suspected history of alcohol or drug abuse
- Affiliation with the investigational site
- Previous use of GSK573719 or the combination of GSK573719/GW642444
Data sourced from ClinicalTrials.gov (NCT01387230). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.