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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 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 425 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03012061
The ClinicalTrials.gov registry entry for NCT03012061 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 425 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT03012061 reports 0 study locations.
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.
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