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NCT01316913 · ClinicalTrials.gov registry record · Phase 3
24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 872
- Enrollment target
NCT01316913: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01316913 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 872 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316913, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 872 participants
- Enrollment target
Study 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, GSK573719 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.
Primary Outcome
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 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (i.e., trough FEV1 on Day 169 i
Interventions
- DRUG GSK573719/GW642444 125/25
- DRUG GSK573719/GW642444 62.5/25
- DRUG tiotropium bromide
- DRUG GSK573719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 872 participants |
| Start Date | 2011-03 |
| Est. Completion | 2012-04 |
| Phase | Phase 3 |
What the finished NCT01316913 record still lists
NCT01316913 is an interventional study that assigns participants to a tested intervention. The registered 872 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 4 interventions - of which GSK573719/GW642444 125/25 is the first listed.
NCT01316913 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01316913 about?
NCT01316913 is a clinical study titled "24-week Trial Comparing GSK573719/GW642444 With GSK573719 and With Tiotropium in Chronic Obstructive Pulmonary Disease". 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, GSK573719 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-dail...
What is the current status of trial NCT01316913?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 872 participants. The study started on 2011-03. Estimated completion is 2012-04.
What interventions are being tested in trial NCT01316913?
The interventions under investigation include: GSK573719/GW642444 125/25 (DRUG), GSK573719/GW642444 62.5/25 (DRUG), tiotropium bromide (DRUG), GSK573719 (DRUG).
Who is sponsoring clinical trial NCT01316913?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01316913's enrollment target sits among peer trials
872 373rd of 2000 higher than 1,628 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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