Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563102
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
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:
None
Organization:
None
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:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 albuterolbudesonide 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 albuterolbudesonide 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None