Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
NCT Number: NCT06563102
Acronym: DARWIN
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Mild Asthma
Interventions: COMBINATION_PRODUCT: Albuterol/Budesonide|COMBINATION_PRODUCT: Albuterol
Sponsor: AstraZeneca
Collaborators: Fortrea
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-09-13
Completion Date: 2025-11-10
Locations: Research Site, Phoenix, Arizona, 85040, United States|Research Site, Tucson, Arizona, 85715, United States|Research Site, San Diego, California, 92123, United States|Research Site, Cape Coral, Florida, 33990, United States|Research Site, Columbus, Georgia, 31904, United States|Research Site, Boise, Idaho, 83706, United States|Research Site, Saint Louis, Missouri, 63141, United States|Research Site, Raleigh, North Carolina, 27607, United States|Research Site, North Charleston, South Carolina, 29420, United States|Research Site, El Paso, Texas, 79903, United States|Research Site, Houston, Texas, 77030, United States

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.

Primary Outcome Measures: Change from baseline to maximum value of daily morning FeNO, Change from baseline to maximum value of daily morning FeNO over 12 weeks of treatment in the albuterol/budesonide group compared to the albuterol group., Daily over 12 weeks
Secondary Outcome Measures: Change from baseline in FeNO on high inflammation days, Change from baseline in FeNO on high inflammation days in the albuterol/budesonide group compared to the albuterol group. A high inflammation day is a day in which the FeNO value is ≥ 20 ppb above baseline., Daily over 12 weeks|Number of days with high inflammation (annualized rate), Number of days with high inflammation in the albuterol/budesonide group compared to the albuterol group. A high inflammation day is a day in which the FeNO value is ≥ 20 ppb above baseline., Daily over 12 weeks|Number of days with daily morning FeNO measurements ≥ 50 ppb (annualized rate), Number of days with FeNO \>= 50 ppb in the albuterol/budesonide group compared to the albuterol group., Daily over 12 weeks|Number of days with daily morning FeNO measurements ≥ 25 ppb (annualized rate), Number of days with FeNO \>= 25 ppb in the albuterol/budesonide group compared to the albuterol group., Daily over 12 weeks|Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment, Mean daily change in FeNO from the median of the individual's daily FeNO measures over 12 weeks in the albuterol/budesonide group compared to the albuterol group., Daily over 12 weeks
Other Outcome Measures: Number of SAEs and DAEs, Evaluate the safety and tolerability of albuterol/budesonide compared to albuterol in patients with asthma., Week 12