Phase 3
Completed N=843
24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01316900 ↗
Enrolled (actual)
843
Serious AEs
4.7%
Results posted
Feb 2014
Primary outcomePrimary: Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) — 0.121; 0.211; 0.209; 0.121 Liters — p=<0.001
Summary
This is a Phase III multicenter, randomized, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of two doses of GSK573719/GW642444 Inhalation Powder and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-daily over a 24-week treatment period in subjects with chronic obstructive pulmonary disease (COPD). Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to10 day run-in period followed by a randomization visit (Visit 2) then a 24-week treatment period. There will be a total of 9 clinic study visits. A follow-up phone contact for adverse event assessment will be conducted approximately one week after the last study visit (Visit 9 or Early Withdrawal). The total duration of subject participation in the study will be approximately 26 weeks. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) forced expiratory volume in one second (FEV1) on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, and clinical laboratory tests.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline (BL) in Trough Forced Expiratory Volume in One Second (FEV1) on Day 169 (Week 24) |
0.121; 0.211; 0.209; 0.121 | <0.001 sig |
| SECONDARY Change From Baseline (BL) in Weighted Mean (WM) 0-6 Hour FEV1 Obtained Post-dose at Day 168 |
0.178; 0.254; 0.263; 0.181 | — |
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 1000mcg/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 or roflumilast within 14 days of Visit 1
- use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or inhaled long-acting beta-agonists within 48 hours of Visit 1
- short-acting oral beta-agonists within 12 hours of 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, inhaled short-acting anticholinergics, or inhaled short-acting anticholinergic/short-acting beta-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)
- long-term oxygen therapy prescribed for >12 hours per day
- regular use of nebulized short-acting bronchodilators
- participation in acute phase of pulmonary rehabilitation program
- known or suspected history of alcohol or drug abse within 2 years prior to Visit 1
- anyone affiliated with the investigator site (e.g., investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member)
- previous exposure to GSK573719, GSK573719/GW642444 combination, GW642444 (vilanterol), or fluticasone furoate/GW642444 combination
Data sourced from ClinicalTrials.gov (NCT01316900). 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.