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NCT01328444 · ClinicalTrials.gov registry record · Phase 3
An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 349
- Enrollment target
NCT01328444: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01328444 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 349 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01328444, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 349 participants
- Enrollment target
Study Summary
This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily administration of GSK573719/GW642444 Inhalation Powder (125/25mcg and 62.5/25mcg), GSK573719 Inhalation Powder (125mcg and 62.5mcg), GW642444 Inhalation Powder 25 mcg and placebo delivered by a Novel dry powder inhaler (Novel DPI)
Primary Outcome
Exercise endurance time (EET) post-dose at Week 12 is defined as the EET obtained 3 hours after dosing at Week 12. EET was measured using the externally paced field walking test called the endurance shuttle walk test (ESWT). Analysis performed using a repeated measures model with covariates of period walking speed, mean walking speed, period, treatment, visit, smoking status, center group, visit by period walking speed, visit by mean walking speed and visit by treatment interactions. The model u
Interventions
- DRUG GW642444 25
- DRUG GSK 573719 +GW642444 125/25
- DRUG GSK573719 + GW642444 62.5/25
- DRUG GSK 573719 125
- DRUG GSK 573719 62.5
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 349 participants |
| Start Date | 2011-03-01 |
| Est. Completion | 2012-06-14 |
| Phase | Phase 3 |
What the finished NCT01328444 record still lists
NCT01328444 is an interventional study that assigns participants to a tested intervention. The registered 349 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 (55% lower).
The record links to 0 conditions, and to 5 interventions - of which GW642444 25 is the first listed.
NCT01328444 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01328444 about?
NCT01328444 is a clinical study titled "An Exercise Endurance Study to Evaluate the Effects of Treatment of Chronic Obstructive Pulmonary Disease (COPD) Patients With a Dual Bronchodilator: GSK573719/GW642444. Study A". This is a phase III multicenter, randomized, double-blind, placebo-controlled, combination and component, two-period, incomplete block design cross-over study using GSK573719/GW642444. The primary objective is to evaluate lung function and exercise endurance time after 12 weeks of once-daily adminis...
What is the current status of trial NCT01328444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 349 participants. The study started on 2011-03-01. Estimated completion is 2012-06-14.
What interventions are being tested in trial NCT01328444?
The interventions under investigation include: GW642444 25 (DRUG), GSK 573719 +GW642444 125/25 (DRUG), GSK573719 + GW642444 62.5/25 (DRUG), GSK 573719 125 (DRUG), GSK 573719 62.5 (DRUG).
Who is sponsoring clinical trial NCT01328444?
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 NCT01328444's enrollment target sits among peer trials
349 1045th of 2000 higher than 956 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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