NCT06563102

Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Detailed description

DARWIN is a randomized, active-comparator, double-blind, parallel-group, Phase IV study evaluating the effect of albuterol/budesonide (AIRSUPRA) compared to albuterol administered as-needed in response to symptoms on changes in airway inflammation, asthma symptoms, and rescue therapy utilization in adults with mild asthma. Approximately 15 sites in the United States of America will enroll adult participants with mild asthma who use albuterol as a rescue inhaler and who do not take ICS as maintenance therapy. The study will be divided in 2 periods (Lead-in Period and Treatment Period) and the total duration of the study for each participant could be up to 15 weeks, with a visit frequency of once every 4 weeks: * Lead-In Period: Up to 3 weeks * Treatment Period: 12 weeks

Conditions

• Mild Asthma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-11
• Primary completion: 2026-02-24
• Completion: 2026-02-24
• First posted: 2024-08-20
• Last updated: 2026-02-27

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study