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NCT06307665 · ClinicalTrials.gov registry record · Phase 3
Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma
A Phase 3 study of Asthma, sponsored by AstraZeneca.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT06307665: Recruiting Phase 3 study of Asthma, sponsored by AstraZeneca.
NCT06307665 is a Phase 3 study of Asthma that is actively recruiting participants, run by AstraZeneca. The registered enrollment target is 440 participants, below the 1,562-participant average among 374 other Asthma trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06307665, a Phase 3 study of Asthma, is actively recruiting participants, sponsored by AstraZeneca.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of asthma and at least one severe exacerbation in the prior year.
Primary Outcome
The effect of BDA MDI compared with AS MDI, both administered as needed, on the AAER in participants with asthma will be evaluated.
Conditions Studied
Interventions
- COMBINATION_PRODUCT BDA MDI
- COMBINATION_PRODUCT AS MDI
Study Locations (20)
California
- Research Site - Long Beach
- Research Site - Long Beach
- Research Site - Madera
- Research Site - Mission Viejo
- Research Site - Moreno Valley
- Research Site - Orange
- Research Site - Riverside
- Research Site - San Diego
- Research Site - San Diego
- Research Site - San Francisco
- Research Site - Westminster
Florida
- Research Site - Destin
- Research Site - Jacksonville
- Research Site - Largo
Arizona
- Research Site - Gilbert
- Research Site - Phoenix
Alaska
- Research Site - Anchorage
Arkansas
- Research Site - Little Rock
Colorado
- Research Site - Denver
Delaware
- Research Site - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2024-05-20 |
| Est. Completion | 2027-10-13 |
| Phase | Phase 3 |
What NCT06307665 shows while recruiting
NCT06307665 is an interventional study that assigns participants to a tested intervention. The registered 440 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 (72% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 2 interventions - of which BDA MDI is the first listed.
NCT06307665 names 20 study sites across 7 states, led by California, Florida, Arizona.
Frequently Asked Questions
What is clinical trial NCT06307665 about?
NCT06307665 is a clinical study titled "Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma". The purpose of this study is to compare the effect of budesonide/albuterol metered-dose inhaler (BDA MDI) with albuterol sulfate metered-dose inhaler (AS MDI), both administered as needed, on the annualized rate of severe asthma exacerbations in adolescents with a documented clinical diagnosis of as...
What is the current status of trial NCT06307665?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2024-05-20. Estimated completion is 2027-10-13.
What conditions does trial NCT06307665 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT06307665?
The interventions under investigation include: BDA MDI (COMBINATION_PRODUCT), AS MDI (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06307665?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06307665 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California, Colorado. 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 NCT06307665's enrollment target sits among peer trials
440 85th of 374 higher than 290 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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