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NCT01238861 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma
A Phase 2 study of Asthma, sponsored by MedImmune.
- Completed
- Registry status
- Phase 2
- Development phase
- 964
- Enrollment target
- 20
- Study locations
NCT01238861: Completed Phase 2 study of Asthma, sponsored by MedImmune.
NCT01238861 is a Phase 2 study of Asthma that has completed, run by MedImmune. The registered enrollment target is 964 participants, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (38% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01238861, a Phase 2 study of Asthma, has completed, sponsored by MedImmune.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 964 participants
- Enrollment target
- 20
- Study locations
Study Summary
The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
Primary Outcome
The annual asthma exacerbation rate (AER) was calculated as the total number of observed exacerbations in each group up to week 52, divided by total duration of person-year follow-up in each group. An asthma exacerbation is defined as a progressive increase of asthma symptoms (cough, wheeze, chest tightness, and/or shortness of breath) that does not resolve after the initiation of rescue medications and remains troublesome for the participant resulting in either 1) use of systemic corticosteroid
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Benralizumab 2 mg
- BIOLOGICAL Benralizumab 20 mg
- BIOLOGICAL Benralizumab 100 mg
Study Locations (20)
California
- Research Site - Los Angeles
- Research Site - Orange
- Research Site - San Diego
- Research Site - Stockton
Colorado
- Research Site - Colorado Springs
- Research Site - Denver
Florida
- Research Site - Kissimmee
- Research Site - Tampa
Alabama
- Research Site - Birmingham
Connecticut
- Research Site - Waterbury
Georgia
- Research Site - Stockbridge
Illinois
- Research Site - Normal
Maryland
- Research Site - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 964 participants |
| Start Date | 2010-12 |
| Est. Completion | 2013-08 |
| Phase | Phase 2 |
What the finished NCT01238861 record still lists
NCT01238861 is an interventional study that assigns participants to a tested intervention. The registered 964 participants enrollment target is mid-sized for trials with a published cap, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (38% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01238861 names 20 study sites across 15 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01238861 about?
NCT01238861 is a clinical study titled "Study to Evaluate the Efficacy and Safety of MEDI-563 in Adults With Uncontrolled Asthma". The primary objective of the study is to evaluate the effect of multiple-dose subcutaneous administrations of MEDI-563 on adults with uncontrolled asthma.
What is the current status of trial NCT01238861?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 964 participants. The study started on 2010-12. Estimated completion is 2013-08.
What conditions does trial NCT01238861 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01238861?
The interventions under investigation include: Placebo (OTHER), Benralizumab 2 mg (BIOLOGICAL), Benralizumab 20 mg (BIOLOGICAL), Benralizumab 100 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT01238861?
This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01238861 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01238861's enrollment target sits among peer trials
964 44th of 374 higher than 330 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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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