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NCT01957150 · ClinicalTrials.gov registry record · Phase 4
Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).
A Phase 4 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 4
- Development phase
- 283
- Enrollment target
NCT01957150: Completed Phase 4 study, sponsored by GlaxoSmithKline.
NCT01957150 is a Phase 4 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 283 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01957150, a Phase 4 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 283 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on bone mineral density assessed at the total hip by comparing FF/VI treatment with VI treatment in subjects with moderate COPD.
Primary Outcome
BMD analysis performed on log (BMD ratio to baseline) using a repeated measures model with covariates of treatment group, age, gender, baseline BMI, visit, log baseline BMD, log baseline BMD by visit and treatment group by visit interactions. These estimates were then converted into annual changes and averaged to calculate the overall treatment estimates and difference which were used for testing non-inferiority. The analysis shown is for the "While on Treatment" estimand of the difference in pe
Interventions
- DRUG Fluticasone Furoate/Vilanterol
- DRUG Vilanterol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2014-01-28 |
| Est. Completion | 2018-03-26 |
| Phase | Phase 4 |
What the finished NCT01957150 record still lists
NCT01957150 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluticasone Furoate/Vilanterol is the first listed.
NCT01957150 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01957150 about?
NCT01957150 is a clinical study titled "Study Evaluating the Effect of Fluticasone Furoate/ Vilanterol (FF/VI) Inhalation Powder Compared With Vilanterol (VI) Inhalation Powder on Bone Mineral Density (BMD) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).". This is a multi-center, randomized, double-blind, parallel-group study. The FF/VI inhalation powder once daily and VI inhalation powder once daily will be evaluated in subjects with COPD over 156 weeks. The primary objective of this study is to evaluate the effect of the inhaled corticosteroid FF on...
What is the current status of trial NCT01957150?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 283 participants. The study started on 2014-01-28. Estimated completion is 2018-03-26.
What interventions are being tested in trial NCT01957150?
The interventions under investigation include: Fluticasone Furoate/Vilanterol (DRUG), Vilanterol (DRUG).
Who is sponsoring clinical trial NCT01957150?
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 NCT01957150's enrollment target sits among peer trials
283 303rd of 2000 higher than 1,698 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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