Viewing Study NCT06502366



Ignite Creation Date: 2024-10-26 @ 3:34 PM
Last Modification Date: 2024-10-26 @ 3:34 PM
Study NCT ID: NCT06502366
Status: RECRUITING
Last Update Posted: None
First Post: 2024-07-09

Brief Title: A Study to Investigate the Effect on Lung Function of BDA Formulated With a New Propellant HFO Compared With an Approved Asthma Treatment BDA With HFA Propellant in Participants With Asthma
Sponsor: None
Organization: None

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: 2024-07
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: 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 screeningrun-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: 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