Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
NCT06563102 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 101
Last updated 2026-02-27
Summary
The purpose of this study is to compare the efficacy and safety of albuterol/budesonide to albuterol in changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma.
Study details include:
* The study duration will be up to 15 weeks.
* The treatment duration will be 12 weeks.
* The visit frequency will be once every 4 weeks, with 3 clinic visits and 2 video calls in total.
Conditions
- Mild Asthma
Interventions
- COMBINATION_PRODUCT
-
Albuterol/Budesonide
Oral Inhalation. Rescue medication. Unit dose strength of 80 μg budesonide and 90 μg albuterol per actuation
- COMBINATION_PRODUCT
-
Albuterol
Oral Inhalation. Rescue medication. Unit dose strength of 90μg albuterol per actuation.
Sponsors & Collaborators
-
Fortrea
collaborator INDUSTRY - lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-11
- Primary Completion
- 2026-02-24
- Completion
- 2026-02-24
- FDA Drug
- Yes
Countries
- United States
Study Locations
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