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.
• 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
• 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