Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-04 @ 8:33 AM
Study NCT ID:
NCT06502366
Status:
RECRUITING
Last Update Posted:
2025-12-15
First Post:
2024-07-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Effect on Lung Function of BDA Formulated With a Next Generation Propellant Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
Sponsor:
AstraZeneca
Organization:
Study Overview
Official Title:
A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared With BDA Delivered by MDI HFA in Participants With Asthma
Status:
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:
None
Brief Summary:
The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.
Detailed Description:
The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.
The study duration for each participant will be approximately 14 to 15 weeks and will consist of:
1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention
2. 3 treatment periods of 4 weeks each
3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention
Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).
The study duration for each participant will be approximately 14 to 15 weeks and will consist of:
1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention
2. 3 treatment periods of 4 weeks each
3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention
Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).
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?: