Study identifier:D6930C00018
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
A 12-week, Randomized, Double-Blind, Phase 4 Study Evaluating the Effect of AIRSUPRA Compared to Albuterol Administered as Needed on Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization in Adults with Mild Asthma
Mild Asthma
Phase 4
No
Albuterol/Budesonide, Albuterol
All
100
Interventional
18 Years - 120 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
Fortrea
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Group 1 - Participants randomized to receive albuterol/budesonide Participants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy. | Combination Product: Albuterol/Budesonide Oral Inhalation. Rescue medication. Unit dose strength of 80 μg budesonide and 90 μg albuterol per actuation Other Name: AIRSUPRA Other Name: BDA MDI HFA |
Active Comparator: Group 2 - Participants randomized to receive albuterol Participants will be randomized based on Visit 1 FeNO levels (< 50 ppb / ≥ 50 ppb) and geographic region. Participants who are randomized to receive albuterol/budesonide for as-needed rescue therapy will be compared to participants randomized to receive albuterol for as-needed rescue therapy. | Combination Product: Albuterol Oral Inhalation. Rescue medication. Unit dose strength of 90μg albuterol per actuation. Other Name: AS MDI |