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NCT01072149 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
NCT01072149: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01072149 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 54 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072149, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
Study Summary
The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with placebo. Other objectives are to assess additional efficacy, plus the safety, pharmcodynamics and tolerability of concurrent treatment with Fluticasone Furoate (FF) plus GW642444 when administered at three dose levels for 28 days in subjects with COPD and to assess the steady-state pharmacokinetic profile of Fluticasone Furoatee (FF) and GW642444 at the end of each treatment period.
Primary Outcome
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation. The weighted mean was calculated from pre-dose FEV1 (calculated as the mean of the -30 and -5 minute measurements) and post-dose FEV1 after 5, 15, 30, and 60 minutes and after 2, 4, 6, 8, 12, 16, 20, 22, 23, and 24 hours. Data are provided as the Least Squares Mean of the weighted mean for all three treatment periods. Analysis was performed using a mixed effects model with
Interventions
- DEVICE placebo
- DRUG Fluticasone Furoate (FF)/GW642444 Inhalation Powder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2010-01-01 |
| Est. Completion | 2010-07-01 |
| Phase | Phase 3 |
What the finished NCT01072149 record still lists
NCT01072149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT01072149 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01072149 about?
NCT01072149 is a clinical study titled "A Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetic (PK), and Pharmacodynamic (PD) Profiles of 3 Doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the End of a 28-day Treatment Period in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Compared to Placebo". The Purpose of this study is to evaluate the 24-hour spirometry effect Forced Expiratory Volume in One second (FEV1) of 3 doses of Fluticasone Furoate (FF)/GW642444 Inhalation Powder at the end of a 28-day treatment period in subjects with Chronic Obstructive Pulmonary Disease (COPD) compared with p...
What is the current status of trial NCT01072149?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2010-01-01. Estimated completion is 2010-07-01.
What interventions are being tested in trial NCT01072149?
The interventions under investigation include: placebo (DEVICE), Fluticasone Furoate (FF)/GW642444 Inhalation Powder (DRUG).
Who is sponsoring clinical trial NCT01072149?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01072149's enrollment target sits among peer trials
54 1838th of 2000 higher than 162 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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