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AstraZeneca (AIRSUPRA) 18 YEARS OF AGE. ASTHMA STUDY
If you are interested in participating and believe you meet the requirements, please contact our research staff to learn more at 502.368.0732.
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AstraZeneca (AIRSUPRA) 18 YEARS OF AGE. {ASTHMA STUDY}
- Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared with BDA Delivered by MDI HFA in Participants with Asthma
- This study will 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.
- Duration: Approximately 14 to 15 weeks. A screening and placebo run-in period of 2 weeks prior to the first dose of study intervention. 3 treatment periods of 4 weeks each. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention.
Key Exclusion:
18 years of age
- Bronchodilator responsiveness to albuterol is defined as a > 12% and > 200 mL increase in FEV1 relative to baseline following administration of albuterol.
- Participants who have physician diagnosed asthma as defined by GINA (GINA, 2023) for at least 12 months prior to Visit 1.
- Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA
- Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose
- ICS-LABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.
Key Exclusion:
- Diagnosis of COPD
- Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1
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