Ignite Creation Date:
2024-07-17 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471257
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-05-29
Brief Title:
A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
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
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BAIYUN
Brief 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 11 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment
BDA MDI 160180 μg administered as 2 actuations of BDA MDI 8090 µg as needed
AS MDI 180 μg administered as 2 actuations of AS MDI 90 μg as needed
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 11 ratio to receive one of the following 2 treatments to be used as reliever therapy on top of usual maintenance treatment
BDA MDI 160180 μg administered as 2 actuations of BDA MDI 8090 µg as needed
AS MDI 180 μg administered as 2 actuations of AS MDI 90 μg as needed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None