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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
NCT01323660 · View on ClinicalTrials.gov ↗
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01323660
The ClinicalTrials.gov registry entry for NCT01323660 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 307 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01323660 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Georgia, Missouri, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01323660?
This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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