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NCT01313637 · ClinicalTrials.gov registry record · Phase 3
A 24-week Evaluation of GSK573719/Vilanterol (125/25mcg) and Components in COPD
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,493
- Enrollment target
- 20
- Study locations
NCT01313637: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT01313637 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 1,493 participants, above the 1,024-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (46% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01313637, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,493 participants
- Enrollment target
- 20
- Study locations
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).
Primary Outcome
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 measurements were taken electronically by spirometry on Days 2, 28, 56, 84, 112, 168, and 169. Baseline is defined as the mean of the assessments made 30 minutes pre-dose and 5 minutes pre-dose on Treatment Day 1. Trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24 hours after the previous morning's dosing (ie., trough FEV1 on Day 169 is
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 |
What the finished NCT01313637 record still lists
NCT01313637 is an interventional study that assigns participants to a tested intervention. Its 1,493 participants enrollment target places it among the larger protocols in the corpus, above the 1,024-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (46% higher).
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.
NCT01313637 names 20 study sites across 11 states, led by California, Florida, Alabama.
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.
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).
Who is sponsoring clinical trial NCT01313637?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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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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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