Number TYPE Age Range Length of Study Compensation
D6933C00002 Asthma Adult 18 and up Approx. 12 weeks Time/Travel
A Randomized, Placebo-Controlled, Double-blind, Multi-center, 4-Week, 3-way, 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
Inclusion Criteria:
1) ≥18 years of age
2) Diagnosis of asthma as defined by GINA 2023 criteria
3) Receiving one of the following four asthma treatment options for a minimum of three months prior to enrollment: a. SABA PRN
b. Daily low-dose ICS in addition to PRN use of SABA. Low-dose ICS dosing is defined byGINA 2023 criteria (see Section 2.5)
c. Concomitant ICS with SABA PRN
d. Low-dose ICS-formoterol PRN. Low-dose ICS dosing is defined by GINA 2023 criteria (see Section 2.5) OR receiving the following asthma treatment options for a minimum of six months prior to enrollment:
a. Daily low-dose ICS-formoterol (in addition to SABA PRN or low-dose ICS-formoterol PRN)
4) Pre-bronchodilator FEV1 of ≥60 to <90% predicted normal value confirmed at Visit 1
5) Bronchodilator responsiveness as defined by >12% and >200 mL in FEV1 relative to baseline after administration of SABA at Visit 2
Exclusion Criteria:
1) other significant obstructive (e.g., COPD) and/or restrictive lung disease, 2) demonstrating worsening asthma control during the run-in period on placebo using ePRO device alerts for significant changes in bi-daily peak flows, bi-daily asthma symptoms and/or SABA PRN administration, 3) respiratory failure secondary to an asthma episode(s) within 5 years of enrollment, 4)hospitalizations due to asthma within 6 months prior to enrollment, 5) Systemic corticosteroids (SCS) use (any dose and any indication) within 6 months before enrollment.
1) ≥18 years of age
2) Diagnosis of asthma as defined by GINA 2023 criteria
3) Receiving one of the following four asthma treatment options for a minimum of three months prior to enrollment: a. SABA PRN
b. Daily low-dose ICS in addition to PRN use of SABA. Low-dose ICS dosing is defined byGINA 2023 criteria (see Section 2.5)
c. Concomitant ICS with SABA PRN
d. Low-dose ICS-formoterol PRN. Low-dose ICS dosing is defined by GINA 2023 criteria (see Section 2.5) OR receiving the following asthma treatment options for a minimum of six months prior to enrollment:
a. Daily low-dose ICS-formoterol (in addition to SABA PRN or low-dose ICS-formoterol PRN)
4) Pre-bronchodilator FEV1 of ≥60 to <90% predicted normal value confirmed at Visit 1
5) Bronchodilator responsiveness as defined by >12% and >200 mL in FEV1 relative to baseline after administration of SABA at Visit 2
Exclusion Criteria:
1) other significant obstructive (e.g., COPD) and/or restrictive lung disease, 2) demonstrating worsening asthma control during the run-in period on placebo using ePRO device alerts for significant changes in bi-daily peak flows, bi-daily asthma symptoms and/or SABA PRN administration, 3) respiratory failure secondary to an asthma episode(s) within 5 years of enrollment, 4)hospitalizations due to asthma within 6 months prior to enrollment, 5) Systemic corticosteroids (SCS) use (any dose and any indication) within 6 months before enrollment.