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NCT03170271 · ClinicalTrials.gov registry record · Phase 3
A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.
A Phase 3 study of Asthma, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 3
- Development phase
- 660
- Enrollment target
- 20
- Study locations
NCT03170271: Completed Phase 3 study of Asthma, sponsored by AstraZeneca.
NCT03170271 is a Phase 3 study of Asthma that has completed, run by AstraZeneca. The registered enrollment target is 660 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03170271, a Phase 3 study of Asthma, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 660 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assessed for their ongoing chronic rhinosinusitis with nasal polyps. The study design has been updated to include a 56-week open label ANDHI in Practice (ANDHI IP) sub study upon the completion of the 24-week double-blind period of the ANDHI study.
Primary Outcome
An asthma exacerbation was defined as a worsening of asthma that led to any of the following: * Use of systemic corticosteroids (or temporary increase in stable oral corticosteroids \[OCS\] background dose) for at least 3 days; a single depo-injectable dose of corticosteroids was considered equivalent to a 3-day course of systemic corticosteroids. * An emergency room/urgent care visit (defined as evaluation and treatment for \< 24 hours in an emergency department or urgent care center) due to a
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Benralizumab (Medi-563)
Study Locations (20)
California
- Research Site - Bakersfield
- Research Site - Encinitas
- Research Site - Long Beach
- Research Site - Los Angeles
- Research Site - Mission Viejo
- Research Site - Newport Beach
- Research Site - Riverside
- Research Site - San Diego
- Research Site - Stockton
- Research Site - Walnut Creek
Florida
- Research Site - Clearwater
- Research Site - Jacksonville
- Research Site - Kissimmee
- Research Site - Miami
Connecticut
- Research Site - New Haven
- Research Site - Waterbury
Alabama
- Research Site - Birmingham
Arizona
- Research Site - Tucson
Arkansas
- Research Site - Little Rock
Colorado
- Research Site - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 660 participants |
| Start Date | 2017-07-07 |
| Est. Completion | 2020-10-21 |
| Phase | Phase 3 |
What the finished NCT03170271 record still lists
NCT03170271 is an interventional study that assigns participants to a tested intervention. The registered 660 participants enrollment target is mid-sized for trials with a published cap, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (58% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03170271 names 20 study sites across 7 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT03170271 about?
NCT03170271 is a clinical study titled "A Study of the Safety and Effectiveness of Benralizumab to Treat Patients With Severe Uncontrolled Asthma.". The purpose of this study is to investigate the effect of benralizumab on the rate of asthma exacerbations, patient reported quality of life and lung function during the 24-week treatment in patients with uncontrolled, severe asthma with an eosinophilic phenotype. A subset of patients will be assess...
What is the current status of trial NCT03170271?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 660 participants. The study started on 2017-07-07. Estimated completion is 2020-10-21.
What conditions does trial NCT03170271 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT03170271?
The interventions under investigation include: Placebo (DRUG), Benralizumab (Medi-563) (DRUG).
Who is sponsoring clinical trial NCT03170271?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03170271 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03170271's enrollment target sits among peer trials
660 60th of 374 higher than 315 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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