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Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

CompletedPhase 2

Sponsor: University of Miami

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Bevespi, Bretzri

Countries: United States

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 overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (1)

Miami, Florida, United States