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NCT01387230 · ClinicalTrials.gov registry record · Phase 3
Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 206
- Enrollment target
NCT01387230: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01387230 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 206 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01387230, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 206 participants
- Enrollment target
Study 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).
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, 14, 28, 56, 84, and 85. 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 (ie., trough FEV1 on Day 85 is the mea
Interventions
- OTHER Placebo
- DRUG GSK573719
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 206 participants |
| Start Date | 2011-07-01 |
| Est. Completion | 2012-02-13 |
| Phase | Phase 3 |
What the finished NCT01387230 record still lists
NCT01387230 is an interventional study that assigns participants to a tested intervention. The registered 206 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01387230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01387230 about?
NCT01387230 is a clinical study titled "Evaluate the Efficacy and Safety of GSK573719 Delivered Via a Novel Dry Powder Inhaler in Subjects With COPD". 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).
What is the current status of trial NCT01387230?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 206 participants. The study started on 2011-07-01. Estimated completion is 2012-02-13.
What interventions are being tested in trial NCT01387230?
The interventions under investigation include: Placebo (OTHER), GSK573719 (DRUG).
Who is sponsoring clinical trial NCT01387230?
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 NCT01387230's enrollment target sits among peer trials
206 1347th of 2000 higher than 651 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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