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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)
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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Research Site
Baotou, China
Research Site
Baotou, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Changchun, China
Research Site
Changsha, China
Research Site
Changsha, China
Start Date
June 17, 2024
Primary Completion Date
October 30, 2026
Completion Date
October 30, 2026
Last Updated
March 17, 2026
790
ESTIMATED participants
Budesonide/Albuterol metered dose inhaler, MDI
COMBINATION_PRODUCT
Albuterol sulfate metered dose inhaler, MDI
COMBINATION_PRODUCT
AstraZeneca Clinical Study Information Center
CONTACT
1-877-240-9479information.center@astrazeneca.comLead Sponsor
AstraZeneca
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07219173