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Clinical Trial Summary

This is a 24 week study to evaluate the efficacy and safety of budesonide and formoterol fumarate metered dose inhaler in adults and adolescents with inadequately controlled asthma.


Clinical Trial Description

This is a Phase III randomized, double-blind, active comparison, parallel group, multicenter study comparing BFF MDI 320/9.6 μg to BD MDI 320 µg and open-label Symbicort TBH 320/9 μg in adult and adolescent participants who have asthma which remains inadequately controlled (ACQ-7 total score ≥ 1.5) despite treatment with medium dose ICS or ICS/LABA. Budesonide and Formoterol Fumarate MDI 160/9.6 μg is included in this study to evaluate dose response by comparing to BFF MDI 320/9.6 μg. All doses represent the sum of 2 actuations. All study interventions will be administered BID for 24 weeks. This study will be conducted at approximately 125 sites worldwide and will randomize approximately 630 adult and adolescent participants. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05202262
Study type Interventional
Source AstraZeneca
Contact AstraZeneca Clinical Study Information Center
Phone 1-877-240-9479
Email [email protected]
Status Recruiting
Phase Phase 3
Start date January 12, 2022
Completion date October 2, 2023

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