A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
Public ClinicalTrials.gov record NCT01313637. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT01313637
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,493 participants
Conditions and interventions
Conditions
Interventions
- GSK573719/GW642444 125/25mcg Drug
- GSK573719 125mcg Drug
- GW642444 25mcg Drug
- Placebo only Drug
Drug
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 28, 2011
- Primary completion
- Feb 29, 2012
- Completion
- Apr 18, 2012
- Last update posted
- Jan 28, 2018
2011 – 2012
United States locations
- U.S. sites
- 24
- U.S. states
- 12
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Jasper | Alabama | 35501 | — |
| GSK Investigational Site | Phoenix | Arizona | 85006 | — |
| GSK Investigational Site | Long Beach | California | 90822 | — |
| GSK Investigational Site | Los Angeles | California | 90095 | — |
| GSK Investigational Site | Palo Alto | California | 94304 | — |
| GSK Investigational Site | Riverside | California | 92506 | — |
| GSK Investigational Site | San Diego | California | 92103-8415 | — |
| GSK Investigational Site | San Diego | California | 92117 | — |
| GSK Investigational Site | Torrance | California | 90502 | — |
| GSK Investigational Site | Clearwater | Florida | 33765 | — |
| GSK Investigational Site | DeLand | Florida | 32720 | — |
| GSK Investigational Site | Orlando | Florida | 32822 | — |
| GSK Investigational Site | Panama City | Florida | 32405 | — |
| GSK Investigational Site | Topeka | Kansas | 66606 | — |
| GSK Investigational Site | Livonia | Michigan | 48152 | — |
| GSK Investigational Site | Plymouth | Minnesota | 55441 | — |
| GSK Investigational Site | Lincoln | Nebraska | 68506 | — |
| GSK Investigational Site | Cherry Hill | New Jersey | 08003 | — |
| GSK Investigational Site | Charlotte | North Carolina | 28207 | — |
| GSK Investigational Site | Easley | South Carolina | 29640 | — |
| GSK Investigational Site | Greenville | South Carolina | 29615 | — |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | — |
| GSK Investigational Site | Union | South Carolina | 29379 | — |
| GSK Investigational Site | Richmond | Virginia | 23225 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 133 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01313637, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 28, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01313637 live on ClinicalTrials.gov.