Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease
Eligibility Criteria
Inclusion Criteria: physician diagnosis of COPD former smoking history of more than 10 pack-years baseline post-bronchodilator one-second forced expiratory volume (FEV1) 50-80% of predicted, baseline FEV1 and forced vital capacity (FVC) ratio <0.7 males and females, 40-80 years of age regular use of a LAMA/LABA drug regimen for at least a month Exclusion Criteria: women of childbearing potential who do not use accepted birth- control measures pregnant and breast-feeding women respiratory infection within 4 weeks of a test day a Corona Virus Disease (COVID) vaccination <3 months prior to study entry ICS use (within 4 weeks of study entry) ICS hypersensitivity albuterol intolerance use of beta-blocker medication (oral and ophthalmic) use of systemic glucocorticosteroid medication within 6 wk prior to the screening visit an acute COPD exacerbation within 6 wk of the screening day (defined as a need for antibiotic or systemic glucocorticoid therapy or emergency department (ED) visit/hospitalization) current smoking or vaping tobacco or other products Oxygen (O2) saturation of <90% at-rest breathing room air Long-term oxygen therapy (LTOT) required at rest regular use of pulmonary vasodilators systemic arterial systolic pressure >150 mmHg and diastolic pressure >100 mmHg on the test day a >40mmHg right ventricular systolic pressure (RVSP) by prior echocardiography a documented COVID infection within 4 weeks of the screening day Regular use of home oxygen at rest Physician diagnosis of obesity hypoventilation syndrome
Sites / Locations
- University of MiamiRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Bretzri followed by Bevespi Group
Bevespi followed by Bretzri Group
Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.
Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.