NCT06471257

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma

A Randomized, Double-blind, Multicentre, Event-driven, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Symptomatic Chinese Adults With Asthma (BAIYUN)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 790 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An event-driven, Phase III study to evaluate the efficacy and safety of BDA MDI compared with AS MDI in reducing the risk of a severe asthma exacerbation in symptomatic Chinese adults with asthma.

Detailed description

This is a randomized, double-blind, multicenter, event-driven, parallel group, Phase III study to assess the efficacy and safety of budesonide and albuterol metered dose inhaler (MDI) versus albuterol sulfate (AS) MDI in symptomatic Chinese adults with asthma. Both treatments will be administered as needed in response to asthma symptoms or prior to exercise. Approximately 790 participants who meet the eligibility criteria will be randomized. The study will consist of 3 periods: 1. Screening period: 14 to 28 days 2. Treatment period: minimum of 24 weeks and maximum of 52 weeks 3. Safety follow-up period: occur 2 weeks (± 4 days) after Visit 8, EOS or PDV, whichever occurs first 790 participants who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment: * BDA MDI 160/180 μg (administered as 2 actuations of BDA MDI 80/90 µg) as needed * AS MDI 180 μg (administered as 2 actuations of AS MDI 90 μg) as needed

Conditions

• Asthma

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Budesonide/Albuterol metered dose inhaler, MDI	Combination Product (Drug + Device)
COMBINATION_PRODUCT	Albuterol sulfate metered dose inhaler, MDI	Combination Product (Drug + Device)

Timeline

• Start date: 2024-06-17
• Primary completion: 2026-10-30
• Completion: 2026-10-30
• First posted: 2024-06-24
• Last updated: 2026-04-14

Locations

102 sites across 2 countries: China, Hong Kong