Overview
The study objective is to determine whether an ICS added for 4 weeks to a baseline treatment with a Long-Acting Beta-adrenergic Agonist (LABA) and Long-Acting Muscarinic Antagonist (LAMA) combination improves pulmonary vascular endothelial function as assessed by the vasodilator response to inhaled albuterol (endothelium-dependent vasodilation) in stable COPD patients treated with a LABA/LAMA without an ICS for at least one month.
Eligibility
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