Tests an inhaler combining budesonide and albuterol against albuterol alone for asthma

Trial details

Who runs it

AstraZeneca

Trial code

NCT06471257

Record updated

21 September 2026

Original description

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.Read full original descriptionShow less

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.

Inclusion: Documented physician-diagnosed asthma for at least 12 months prior to Visit 1; Receiving 1 of the scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before Visit 1; Pre-bronchodilator FEV1 of ≥ 40% to < 90% predicted normal value for adults; Documented reversibility to albuterol; A documented history of at least one severe asthma exacerbation within 12 months before Visit 1; ACQ-7 score ≥ 1.5 assessed at Visit 1; ACQ-5 score ≥ 1.5 assessed at Visit 2; Receiving inhaled SABA as needed prior to Visit 1 for at least 3 months; Use of Sponsor-provided salbutamol sulfate inhalation aerosol as needed medication due to asthma symptoms on at least 3 days during the last week of the run-in period before Visit 2; Demonstrate acceptable MDI administration technique as assessed by the investigator; use of spacers is prohibited; Able to perform acceptable and reproducible PEF measurements as assessed by the investigator; BMI < 40 kg/m2; Negative pregnancy test (urine at Visit 1) for female participants of childbearing potential; Women of childbearing potential must agree to prevent pregnancy; Compliance: must be willing to remain at the study site as required per protocol and complete all visit assessments.

Exclusion: Oral/SCS use (any dose) within 6 weeks before Visit 1; Chronic use of OCS ≥ 3 weeks use in 3 months prior to Visit 1; Having received any marketed or investigational biologic within 3 months or 5 half-lives before Visit 1, whichever is longer, or any other prohibited medication; Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months before Visit 1; Upper respiratory infection involving antibiotic treatment not resolved within 7 days before Visit 1; Inability to abstain from protocol-defined prohibited medications during the study; Having received a live attenuated vaccination within 7 days of Visit 1; Chronic obstructive pulmonary disease or other significant lung disease; Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within last 5 years of Visit 1; Completed treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1; Historical or current evidence of a clinically significant disease; Cancer not in complete remission for at least 5 years before Visit 1; History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity; Have a known or suspected hypersensitivity to albuterol/salbutamol, or budesonide and/or their excipients; Clinically significant laboratory abnormalities; Currently pregnant or breastfeeding; Participants who experience > 1 asthma exacerbation during the screening period.

ClinicalTrials.gov NCT06471257