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NCT01323660 · 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 B
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 307
- Enrollment target
- 20
- Study locations
NCT01323660: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT01323660 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 307 participants, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01323660, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 307 participants
- Enrollment target
- 20
- Study locations
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
Conditions Studied
Interventions
- DRUG GSK573719/GW642444 125/25
- DRUG GSK573719/GW642444 62.5/25
- DRUG GSK573719 125
- DRUG GSK573719 62.5
- DRUG GW642444 25
Study Locations (20)
Georgia
- GSK Investigational Site - Austell
- GSK Investigational Site - Lawrenceville
Missouri
- GSK Investigational Site - Saint Charles
- GSK Investigational Site - St Louis
South Carolina
- GSK Investigational Site - Charleston
- GSK Investigational Site - Easley
Texas
- GSK Investigational Site - Austin
- GSK Investigational Site - The Woodlands
Ontario
- GSK Investigational Site - Hamilton
- GSK Investigational Site - Toronto
Alabama
- GSK Investigational Site - Jasper
California
- GSK Investigational Site - Torrance
Colorado
- GSK Investigational Site - Fort Collins
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 307 participants |
| Start Date | 2011-03-16 |
| Est. Completion | 2012-07-16 |
| Phase | Phase 3 |
What the finished NCT01323660 record still lists
NCT01323660 is an interventional study that assigns participants to a tested intervention. The registered 307 participants enrollment target is mid-sized for trials with a published cap, below the 1,040-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Pulmonary Disease, Chronic Obstructive appearing as the primary indexed condition, and to 5 interventions - of which GSK573719/GW642444 125/25 is the first listed.
NCT01323660 names 20 study sites across 15 states, led by Georgia, Missouri, South Carolina.
Frequently Asked Questions
What is clinical trial NCT01323660 about?
NCT01323660 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 B". 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 NCT01323660?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 307 participants. The study started on 2011-03-16. Estimated completion is 2012-07-16.
What conditions does trial NCT01323660 study?
This clinical trial studies the following conditions: Pulmonary Disease, Chronic Obstructive.
What interventions are being tested in trial NCT01323660?
The interventions under investigation include: GSK573719/GW642444 125/25 (DRUG), GSK573719/GW642444 62.5/25 (DRUG), GSK573719 125 (DRUG), GSK573719 62.5 (DRUG), GW642444 25 (DRUG).
Who is sponsoring clinical trial NCT01323660?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01323660 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01323660's enrollment target sits among peer trials
307 35th of 74 higher than 40 of 74 other Pulmonary Disease, Chronic Obstructive trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Disease, Chronic Obstructive 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.
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