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NCT03012061 · ClinicalTrials.gov registry record · Phase 2
Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 425
- Enrollment target
NCT03012061: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT03012061 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 425 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (220% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03012061, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 425 participants
- Enrollment target
Study Summary
This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment. This study will provide important information regarding the efficacy and safety of UMEC when administered in a separate inhaler to subjects on a background of fluticasone furoate (FF). This is a Phase IIb, randomized, double-blind, placebo controlled study that will compare the efficacy, safety and tolerability of UMEC (62.5 mcg and 31.25 mcg) administered once-daily in subjects with asthma that is not well controlled. Eligible subjects will be requested to participate in the study for a maximum of approximately 31 weeks with 4 phases (pre screening, screening/run-in, randomization/treatment and safety follow-up). The total number of randomized subjects required is approximately 384, with 128 subjects randomized 1:1:1 to each of the 3 double-blind treatment arms.
Primary Outcome
FEV1 is measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. The highest of 3 technically acceptable measurements were recorded at each Visit. The Baseline value of clinic FEV1 was last acceptable/borderline acceptable (pre-dose) FEV1 value obtained prior to randomized treatment start date. Change from Baseline was calculated as FEV1 value at Week 24 minus FEV1 value at Baseline. Treatment policy estimand was assessed, including all o
Interventions
- DRUG Placebo
- DRUG UMEC
- DRUG Albuterol/salbutamol
- DRUG Fluticasone Furoate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 425 participants |
| Start Date | 2017-01-25 |
| Est. Completion | 2018-05-30 |
| Phase | Phase 2 |
What the finished NCT03012061 record still lists
NCT03012061 is an interventional study that assigns participants to a tested intervention. The registered 425 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (220% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03012061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03012061 about?
NCT03012061 is a clinical study titled "Phase IIb Study of Umeclidinium (UMEC) Bromide Versus Placebo in Subjects With Asthma". This study is conducted to evaluate the effects of UMEC 62.5 microgram (mcg) and UMEC 31.25 mcg on lung function versus placebo after 24 weeks of treatment. This study will provide important information regarding the efficacy and safety of UMEC when administered in a separate inhaler to subjects on ...
What is the current status of trial NCT03012061?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 425 participants. The study started on 2017-01-25. Estimated completion is 2018-05-30.
What interventions are being tested in trial NCT03012061?
The interventions under investigation include: Placebo (DRUG), UMEC (DRUG), Albuterol/salbutamol (DRUG), Fluticasone Furoate (DRUG).
Who is sponsoring clinical trial NCT03012061?
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 NCT03012061's enrollment target sits among peer trials
425 91st of 2000 higher than 1,910 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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