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NCT06307665Not yet recruiting

Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to 18 Years of Age With Asthma

A Randomized, Double-blind, Multicenter, Parallel Group, Phase IIIb 52 Week Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to 18 Years of Age With Asthma (ACADIA)
AstraZenecaPhase 3ClinicalTrials.govcombination product
Verified
Study focus
Disease/Condition
Asthma
Drug/Device/Intervention
BDA MDI
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
AstraZeneca
Location
White Marsh, United States of America
Timeline & enrollment
Phase
Phase 3
Start date
May 08, 2024
End date
Oct 13, 2027
Enrollment
440 participants
Primary outcome

Annualized rate of severe asthma exacerbations (AAER)

Summary

The purpose of this study is to compare the budesonide/albuterol metered-dose inhaler (BDA
 MDI) with albuterol sulfate metered-dose inhaler (AS MDI) administered as needed on severe
 asthma exacerbations in adolescent participants aged 12 to 18 years with a documented
 clinical diagnosis of asthma and at least one severe exacerbation in the prior year.

ICD-10 classifications
AsthmaAsthma, unspecifiedNonallergic asthmaMixed asthmaPredominantly allergic asthma
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06307665
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06307665 through Pure Global AI's free database. This Phase 3 trial is sponsored by AstraZeneca and is currently Not yet recruiting. The study focuses on Asthma. Target enrollment is 440 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.