This is a 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD.
This is a multicenter, randomized, double-blind, parallel-group, 12-week chronic-dosing study to assess the efficacy and safety of BGF MDI compared to BFF MDI in subjects with moderate to very severe COPD. The study has a total of 7 visits over a Screening Period of up to 28 days and a Treatment Period of 12 weeks followed by a telephone follow-up call 14 days after the last dose of study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
Forced expiratory volume area under the curve from 0 to 4 hours (AUC0-4)
Time frame: Week 12
Change from baseline in morning pre-dose trough FEV1
Time frame: Week 12
Peak change from baseline in inspiratory capacity
Time frame: Week 12
Percentage of subjects achieving a minimally clinical important difference (MCID) of 4 units or more in St. George's Respiratory Questionnaire (SGRQ)
Time frame: Week 12
Time to first clinically important deterioration (CID) in COPD
Time frame: 12 weeks
Change from baseline in average daily rescue Ventolin HFA use
Time frame: 12 weeks
Peak change from baseline in FEV1
Time frame: Week 12
Time to onset of action
Time frame: Day 1
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