Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
NCT ID:
NCT06471257
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 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
Study:
NCT06471257
Study Brief:
Protocol Section:
NCT06471257