A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Chronic obstructive pulmonary disease or other significant lung disease
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
Trial design
Treatments tested in this trial
- Budesonide/Albuterol metered dose inhaler, MDI
- Albuterol sulfate metered dose inhaler, MDI
Treatment groups
1,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov