NCT06502366

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

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: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 422 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	BDA MDI HFO 160/180 μg	Budesonide/albuterol pressurized inhalation suspension, HFO
DRUG	BDA MDI HFA 160/180 μg	Budesonide/albuterol pressurized inhalation suspension, HFA
DRUG	Placebo MDI HFA	Placebo pressurized inhalation suspension, HFA

Timeline

• Start date: 2024-07-22
• Primary completion: 2026-03-03
• Completion: 2026-03-03
• First posted: 2024-07-16
• Last updated: 2026-02-13

Locations

128 sites across 6 countries: United States, China, Malaysia, Mexico, Thailand, Vietnam

Regulatory

• FDA-regulated drug study