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24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
NCT01316900 · View on ClinicalTrials.gov ↗
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 and GW642444 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.
Conditions Studied
Interventions
- DRUG GSK573719/GW642444 125/25
- DRUG GSK573719/GW642444 62.5/25
- DRUG tiotropium bromide
- DRUG GW642444
Study Locations (20)
South Carolina
- GSK Investigational Site — Charleston
- GSK Investigational Site — Gaffney
- GSK Investigational Site — Greenville
- GSK Investigational Site — Rock Hill
- GSK Investigational Site — Seneca
Florida
- GSK Investigational Site — DeLand
- GSK Investigational Site — Orlando
- GSK Investigational Site — Tampa
Virginia
- GSK Investigational Site — Newport News
- GSK Investigational Site — Richmond
Alabama
- GSK Investigational Site — Birmingham
California
- GSK Investigational Site — San Diego
Georgia
- GSK Investigational Site — Decatur
Missouri
- GSK Investigational Site — Saint Charles
New Mexico
- GSK Investigational Site — Albuquerque
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 846 participants |
| Start Date | 2011-03-01 |
| Est. Completion | 2012-04-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01316900
The ClinicalTrials.gov registry entry for NCT01316900 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 846 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 4 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: NCT01316900 reports 20 study locations spanning 13 distinct geographic areas — top geographies include South Carolina, Florida, Virginia. 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 NCT01316900 about?
NCT01316900 is a clinical study titled "24-week Trial Comparing GSK573719/GW642444 With GW642444 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 and GW642444 Inhalation Powder via a Novel Dry Powder Inhaler and tiotropium via HandiHaler when administered once-da...
What is the current status of trial NCT01316900?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 846 participants. The study started on 2011-03-01. Estimated completion is 2012-04-24.
What conditions does trial NCT01316900 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 NCT01316900?
The interventions under investigation include: GSK573719/GW642444 125/25 (DRUG), GSK573719/GW642444 62.5/25 (DRUG), tiotropium bromide (DRUG), GW642444 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01316900?
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 NCT01316900 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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