A Comparison of PT027 vs PT007 Used as Needed in Participants With Asthma

Phase 3 Completed 2516 enrolled Bond Avillion 2 Development LP Parexel · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a US study comparing the efficacy and safety of BDA MDI \[Budesonide/Albuterol Sulfate (BDA) metered dose inhaler (MDI)\] with AS \[Albuterol Sulfate\] MDI, both are administered as needed for up to 12 months.

Timeline

Start: 2022-09-02
Primary completion: 2024-08-22
Completion: 2024-08-22

Outcome

Met primary endpoint

registry analysis (superiority test); BDA MDI (PT027) 160/180 μg vs AS MDI (PT007) 180 µg; p <0.001; Hazard Ratio (HR) 0.535 (95% CI 0.392 to 0.730) NCT05505734 ↗

release “Positive high-level results from the BATURA Phase IIIb trial showed AstraZeneca’s Airsupra (albuterol/budesonide) met the primary endpoint” astrazeneca.com ↗

Publications

LaForce C, Albers F, Danilewicz A, Jeynes-Ellis A, Kraft M, Panettieri RA Jr, Rees R, Bardsley S, Dunsire L, Harrison T, Sobande O, Surujbally R, Trudo F, Cappelletti C, Papi A, Beasley R, Chipps BE, Israel E, Pandya H, Clancy M, Bacharier LB; BATURA Investigators. As-Needed Albuterol-Budesonide in Mild Asthma. N Engl J Med. 2025 Jul 10;393(2):113-124. doi: 10.1056/NEJMoa2504544. Epub 2025 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	160 ug	Inhaled
Subject	Salbutamol	Unknown	180 ug	Inhaled