Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT06563102
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Investigate Changes in Airway Inflammation, Symptoms, and Rescue Therapy Utilization With AIRSUPRA Compared to Albuterol as Needed in Adults With Mild Asthma
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DARWIN
Brief 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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: