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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
422
Budesonide/albuterol pressurized inhalation suspension, HFO
Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo pressurized inhalation suspension, HFA
Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.
Time frame: Change from baseline at Day 29
Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
To demonstrate assay sensitivity via superiority of BDA MDI HFA relative to placebo MDI HFA on lung function in participants with asthma
Time frame: Change from baseline at Day 29
Change from baseline in morning pre-dose trough FEV1
To assess the equivalence of BDA MDI HFO relative to BDA MDI HFA on lung function in participants with asthma.
Time frame: Change from baseline at Day 29
Change from baseline in morning pre-dose trough FEV1
To demonstrate assay sensitivity via superiority of BDA MDI HFA relative to placebo MDI HFA on lung function in participants with asthma
Time frame: Change from baseline at Day 29
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Research Site
Mobile, Alabama, United States
Research Site
Sheffield, Alabama, United States
Research Site
Phoenix, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Encinitas, California, United States
Research Site
Fullerton, California, United States
Research Site
Gardena, California, United States
Research Site
Huntington Beach, California, United States
Research Site
La Mesa, California, United States
Research Site
Los Angeles, California, United States
...and 118 more locations