This study will investigate the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) compared with Placebo MDI, and Budesonide and Formoterol Fumarate (BFF) MDI on isotime inspiratory capacity (IC) and exercise endurance time.
This is a multicenter, three-treatment, three-period, cross-over study to assess the effect of BGF MDI vs Placebo MDI and BFF MDI in participants with COPD who have exertional breathlessness despite treatment with mono or dual COPD maintenance therapy. Eligible participants will be randomized equally (1:1:1:1:1:1) to 1 of 6 treatment sequences. The total duration of the study for each participant will be up to 14 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
171
Randomized participants will receive 2 inhalations of BGF MDI via oral inhalation twice daily (BID).
Randomized participants will receive 2 inhalations of BFF MDI via oral inhalation BID.
Randomized participants will receive 2 inhalations of placebo MDI via oral inhalation BID.
Research Site
Los Angeles, California, United States
Research Site
Tarzana, California, United States
Research Site
Torrance, California, United States
Research Site
Brooksville, Florida, United States
Research Site
Anderson, South Carolina, United States
Research Site
Greenville, South Carolina, United States
Research Site
Spartanburg, South Carolina, United States
Research Site
Edmonton, Alberta, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Sainte-Foy, Quebec, Canada
...and 23 more locations
Change from baseline in isotime Inspiratory capacity (IC)
To assess the effect of BGF MDI relative to Placebo MDI and BGF MDI relative to BFF MDI on dynamic hyperinflation in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in constant work rate cycle ergometry endurance time
To assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on exercise endurance time in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in Isotime dyspnea (NRS)
To assess the effect of BGF MDI relative to Placebo MDI, BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on Isotime dyspnea in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in functional residual capacity (FRC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on FRC in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in total lung capacity (TLC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on TLC in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in residual volume (RV)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in RV/TLC
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on RV/TLC in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in specific airway conductance (sGaw)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on sGaw in participants with COPD.
Time frame: 2 weeks post-treatment
Change from baseline in static Inspiratory capacity (IC)
To assess the effect of BGF MDI relative to BFF MDI and BFF MDI relative to Placebo MDI on static IC in participants with COPD.
Time frame: 2 weeks post-treatment
Number of participants with serious adverse events (SAEs) and adverse event leading to discontinuation of study intervention (DAEs).
To assess the safety and tolerability of BGF MDI and BFF MDI.
Time frame: 2 weeks post-treatment
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