Study identifier:D6933C00002
ClinicalTrials.gov identifier:NCT06502366
EudraCT identifier:N/A
CTIS identifier:N/A
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
asthma
Phase 3
No
BDA MDI HFO 160/180 μg, BDA MDI HFA 160/180 μg, Placebo MDI HFA
All
398
Interventional
18 Years - n/a
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jun 2025 by AstraZeneca
AstraZeneca
-
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 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).
Location
Status
Location
Culiacan, Mexico, 80100
Status
Not yet recruiting
Location
San Juan del Rio, Mexico, 76800
Status
Recruiting
Location
Zapopan, Mexico, 45138
Status
Recruiting
Location
Guadalajara, Mexico, 44130
Status
Not yet recruiting
Location
Mazatlán, Mexico, 82000
Status
Not yet recruiting
Location
Monterrey, Mexico, 64465
Status
Recruiting
Location
Chihuahua, Mexico, 31200
Status
Recruiting
Location
Mexico City, Mexico, 3103
Status
Withdrawn
Arms | Assigned Interventions |
---|---|
Active Comparator: BDA MDI HFO 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO | Drug: BDA MDI HFO 160/180 μg Budesonide/albuterol pressurized inhalation suspension, HFO |
Active Comparator: BDA MDI HFA 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA | Drug: BDA MDI HFA 160/180 μg Budesonide/albuterol pressurized inhalation suspension, HFA |
Placebo Comparator: Placebo MDI HFA Placebo pressurized inhalation suspension, HFA | Drug: Placebo MDI HFA Placebo pressurized inhalation suspension, HFA |
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