NCT06307665

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 440 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a randomized, double-blind, multicenter, parallel-group Phase IIIb study with a fixed treatment period of 52 weeks. The study will consist of 3 periods: 1. Screening period (7 to 28 days) 2. Treatment period of 52 weeks 3. Safety follow-up period (7 to 14 days after the end of treatment \[EOT\] visit) Participants who meet the eligibility criteria will be randomly assigned to BDA MDI 160/180 micrograms (μg) or AS MDI 180 μg treatment groups in a 1:1 ratio on top of their own usual maintenance therapy during treatment period. This study will also include a pharmacokinetic (PK) sub-study with single visit scheduled after the safety follow-up visit in the main study. During PK sub-study, single dose of open-label BDA MDI 160/180 μg will be administered.

Conditions

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	BDA MDI	Participants will receive oral inhalation of BDA MDI 160/180 μg taken as 2 puffs of 80/90 μg as needed.
COMBINATION_PRODUCT	AS MDI	Participants will receive oral inhalation of AS MDI 180 μg taken as 2 puffs of 90 μg as needed.

Timeline

• Start date: 2024-05-20
• Primary completion: 2027-10-13
• Completion: 2027-10-13
• First posted: 2024-03-13
• Last updated: 2026-03-31

Locations

131 sites across 4 countries: United States, China, Mexico, South Africa

Regulatory

• FDA-regulated drug study
• FDA-regulated device study