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NCT01316900 · ClinicalTrials.gov registry record · Phase 3
24-week Trial Comparing GSK573719/GW642444 With GW642444 and With Tiotropium in Chronic Obstructive Pulmonary Disease
A Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 846
- Enrollment target
- 20
- Study locations
NCT01316900: Completed Phase 3 study of Pulmonary Disease, Chronic Obstructive, sponsored by GlaxoSmithKline.
NCT01316900 is a Phase 3 study of Pulmonary Disease, Chronic Obstructive that has completed, run by GlaxoSmithKline. The registered enrollment target is 846 participants, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01316900, a Phase 3 study of Pulmonary Disease, Chronic Obstructive, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 846 participants
- Enrollment target
- 20
- Study locations
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.
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 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 |
What the finished NCT01316900 record still lists
NCT01316900 is an interventional study that assigns participants to a tested intervention. The registered 846 participants enrollment target is mid-sized for trials with a published cap, below the 1,033-participant average among 74 other Pulmonary Disease, Chronic Obstructive trials with a reported enrollment target (18% lower).
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.
NCT01316900 names 20 study sites across 13 states, led by South Carolina, Florida, Virginia.
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.
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).
Who is sponsoring clinical trial NCT01316900?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01316900's enrollment target sits among peer trials
846 18th of 74 higher than 57 of 74 other Pulmonary Disease, Chronic Obstructive trials
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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