A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)
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.
• Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
• the ICF.
• Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
• A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio \< 70%
• at V1.
• 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.
• A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by
• the central laboratory
• A CAT score of ≥ 10 at Visit 1.
• Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below \[(a), (b),
• (c), or (d)\]:
‣ : Established CV Disease
‣ : Combination of CV risk factors:
⁃ Hypertension
• Diabetes Mellitus
• Chronic Kidney Disease
• Dyslipidemia
• Obesity
‣ : High risk of CV disease determined using an established CV risk assessment
∙ tool.
‣ : CT coronary Artery Calcification
• Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as
• required by the protocol.
• Willing to visit at the study site or participate in virtual visits as required per the protocol
• to complete all study assessments.
⁃ A female is eligible to enter and participate in the study if the female is of:
∙ Non-childbearing potential: either permanently sterilized or who are post-menopausal.
‣ Childbearing potential: has a negative serum pregnancy test at V1 and must use one
⁃ highly effective form of birth control.
⁃ Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.