This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.
This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5,000
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
Glycopyrronium and formoterol fumarate pressurized inhalation suspension
Time to first severe cardiac or COPD event
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
Time frame: Up to 3 years
Time to first severe COPD exacerbation event
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe COPD exacerbations.
Time frame: Up to 3 years
Time to first severe cardiac event
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe cardiac outcomes.
Time frame: Up to 3 years
Time to cardiopulmonary death
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary deaths.
Time frame: Up to 3 years
Moderate/severe COPD exacerbation rate
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on moderate/severe COPD exacerbations.
Time frame: Over time, up 3 years
Time to Myocardial Infarction (MI) hospitalization or cardiac death
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to MI hospitalization (or cardiac death).
Time frame: Up to 3 years
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Research Site
Athens, Alabama, United States
TERMINATEDResearch Site
Cullman, Alabama, United States
RECRUITINGResearch Site
Fairhope, Alabama, United States
TERMINATEDResearch Site
Huntsville, Alabama, United States
TERMINATEDResearch Site
Mobile, Alabama, United States
RECRUITINGResearch Site
Sheffield, Alabama, United States
WITHDRAWNResearch Site
Gilbert, Arizona, United States
RECRUITINGResearch Site
Glendale, Arizona, United States
WITHDRAWNResearch Site
Mesa, Arizona, United States
RECRUITINGResearch Site
Mesa, Arizona, United States
RECRUITING...and 911 more locations
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to HF acute healthcare visit/hospitalization (or cardiac death).
Time frame: Up to 3 years