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NCT01181895 · ClinicalTrials.gov registry record · Phase 3
Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 348
- Enrollment target
NCT01181895: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01181895 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 348 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01181895, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 348 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
Primary Outcome
FEV1 is a measure of lung function and is defined as the volume of air that can be forcefully exhaled in one second. The weighted mean is calculated from the pre-dose FEV1 and post-dose FEV1 measurements at 5, 15, and 30 minutes (min) and at 1, 2, 3, 4, 11, 12, 12.5, 13, 14, 16, 20, 23, and 24 hours, respectively, at Week 12. The Baseline value was the Day 1 pre-dose FEV1 measurement. Change from Baseline is calculated as the weighted mean 0-24 hour FEV1 (Liters) at Week 12 minus the Baseline va
Interventions
- DRUG Placebo Inhalation Powder NDPI
- DRUG Vilanterol
- DRUG Salmeterol Inhalation Powder
- DRUG Placebo Inhalation Powder Diskus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 348 participants |
| Start Date | 2010-09-01 |
| Est. Completion | 2011-08-26 |
| Phase | Phase 3 |
What the finished NCT01181895 record still lists
NCT01181895 is an interventional study that assigns participants to a tested intervention. The registered 348 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo Inhalation Powder NDPI is the first listed.
NCT01181895 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01181895 about?
NCT01181895 is a clinical study titled "Study B2C112060: A Study of the Efficacy and Safety of Vilanterol Inhalation Powder in Adults and Adolescents With Persistent Asthma". The objective of this study is to evaluate the efficacy and safety of vilanterol inhalation powder administered once daily in the evening in adolescent and adult subjects 12 years of age and older with persistent asthma over a 12-week treatment period.
What is the current status of trial NCT01181895?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 348 participants. The study started on 2010-09-01. Estimated completion is 2011-08-26.
What interventions are being tested in trial NCT01181895?
The interventions under investigation include: Placebo Inhalation Powder NDPI (DRUG), Vilanterol (DRUG), Salmeterol Inhalation Powder (DRUG), Placebo Inhalation Powder Diskus (DRUG).
Who is sponsoring clinical trial NCT01181895?
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 NCT01181895's enrollment target sits among peer trials
348 1045th of 2000 higher than 953 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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