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Corticosteroid

Group 1 - Participants randomized to receive albuterol/budesonide for Asthma (DARWIN Trial)

Phase 4
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Informed Consent
1 Capable of giving signed informed consent as described in the protocol which included compliance with the requirements and restrictions listed in the ICF and protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12
Awards & highlights

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.

Who is the study for?
This trial is for adults with mild asthma who need to manage inflammation and symptoms. Participants should be able to commit to a study duration of up to 15 weeks, including clinic visits and video calls.
What is being tested?
The study is testing the effectiveness of two treatments: albuterol alone versus a combination of albuterol/budesonide. It focuses on how these treatments affect airway inflammation, control asthma symptoms, and reduce the need for rescue therapy over 12 weeks.
What are the potential side effects?
Possible side effects may include throat irritation, coughing, headaches, or an upset stomach from albuterol; budesonide might cause oral thrush or hoarseness. Each person's reaction can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline to maximum value of daily morning FeNO
Secondary outcome measures
Change from baseline in FeNO on high inflammation days
Mean absolute difference in daily morning FeNO over 12 weeks of randomized treatment
Number of days with daily morning FeNO measurements ≥ 25 ppb (annualized rate)
+2 more
Other outcome measures
Number of SAEs and DAEs

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group 1 - Participants randomized to receive albuterol/budesonideExperimental Treatment1 Intervention
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.
Group II: Group 2 - Participants randomized to receive albuterolActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

FortreaIndustry Sponsor
14 Previous Clinical Trials
3,920 Total Patients Enrolled
AstraZenecaLead Sponsor
4,331 Previous Clinical Trials
288,639,985 Total Patients Enrolled
341 Trials studying Asthma
654,843 Patients Enrolled for Asthma
~67 spots leftby Nov 2025
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