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A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
NCT01313637 · View on ClinicalTrials.gov ↗
Study Summary
This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inhaler over a 24-week treatment period in subjects with COPD. Subjects who meet eligibility criteria at Screening (Visit 1) will complete a 7 to14 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 27 weeks. A subset of subjects at selected sites will also perform 24-hour serial spirometry and Holter monitoring during the study and provide serial blood samples for pharmacokinetic analysis. Sparse pharmacokinetic sampling for population pharmacokinetic analyses will be obtained from non-subset subjects. The primary measure of efficacy is clinic visit trough (pre-bronchodilator and pre-dose) FEV1 on Treatment Day 169. Safety will be assessed by adverse events, 12-lead ECGs, vital signs, clinical laboratory tests, and 24 hour Holter monitoring (subset only).
Conditions Studied
Interventions
- DRUG GW642444 25mcg
- DRUG GSK573719/GW642444 125/25mcg
- DRUG GSK573719 125mcg
- DRUG Placebo only
Study Locations (20)
California
- GSK Investigational Site — Long Beach
- GSK Investigational Site — Los Angeles
- GSK Investigational Site — Palo Alto
- GSK Investigational Site — Riverside
- GSK Investigational Site — San Diego
- GSK Investigational Site — San Diego
- GSK Investigational Site — Torrance
Florida
- GSK Investigational Site — Clearwater
- GSK Investigational Site — DeLand
- GSK Investigational Site — Orlando
- GSK Investigational Site — Panama City
Alabama
- GSK Investigational Site — Jasper
Arizona
- GSK Investigational Site — Phoenix
Kansas
- GSK Investigational Site — Topeka
Michigan
- GSK Investigational Site — Livonia
Minnesota
- GSK Investigational Site — Plymouth
Nebraska
- GSK Investigational Site — Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,493 participants |
| Start Date | 2011-03-01 |
| Est. Completion | 2012-04-19 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01313637
The ClinicalTrials.gov registry entry for NCT01313637 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 1,493 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 GW642444 25mcg 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: NCT01313637 reports 20 study locations spanning 11 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT01313637 about?
NCT01313637 is a clinical study titled "A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD". This is a phase III multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of GSK573719/GW642444 Inhalation Powder, GSK573719 Inhalation Powder, GW642444 Inhalation Powder and Placebo when administered once-daily via a Novel Dry Powder Inh...
What is the current status of trial NCT01313637?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,493 participants. The study started on 2011-03-01. Estimated completion is 2012-04-19.
What conditions does trial NCT01313637 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 NCT01313637?
The interventions under investigation include: GW642444 25mcg (DRUG), GSK573719/GW642444 125/25mcg (DRUG), GSK573719 125mcg (DRUG), Placebo only (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01313637?
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 NCT01313637 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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