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

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.

Timeline

Start

2024-05-20

Primary completion

2027-10-13

Completion

2027-10-13

Publications

• Bacharier LB, Raissy H, Bardsley S, Dunsire L, Hermansson E, Surujbally R, Sobande O, Murphy KR. Efficacy and safety of as-needed albuterol-budesonide versus albuterol in patients with asthma aged 12 to <18 years: design of the randomised, double-blind, parallel-group phase IIIb ACADIA trial. BMJ Open Respir Res. 2026 Mar 6;13(1):e003843. doi: 10.1136/bmjresp-2025-003843.

Drugs

Indications