A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing the ICF. 2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2) 3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70% at V1. 4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking; defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to V1. 5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by the central laboratory 6. A CAT score of ≥ 10 at Visit 1. 7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b), (c), or (d)\]: 1. : Established CV Disease 2. : Combination of CV risk factors: * Hypertension * Diabetes Mellitus * Chronic Kidney Disease * Dyslipidemia * Obesity 3. : High risk of CV disease