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Recruiting
NCT05607719
Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
Conditions: Chronic Obstructive Pulmonary Disease
Sex: All
Ages: 40 Years – 80 Years
Phase: PHASE2
Enrollment: 30
Sponsor: University of Miami
Location: United States
Summary
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 Criteria
Inclusion Criteria:physician diagnosis of COPDformer smoking history of more than 10 pack-yearsbaseline post-bronchodilator one-second forced expiratory volume (FEV1) 50-80% of predicted, baseline FEV1 and forced vital capacity (FVC) ratio <0.7males and females, 40-80 years of ageregular use of a LAMA/LABA drug regimen for at least a monthExclusion Criteria:women of childbearing potential who do not use accepted birth- control measurespregnant and breast-feeding womenrespiratory infection within 4 weeks of a test daya Corona Virus Disease (COVID) vaccination <3 months prior to study entryICS use (within 4 weeks of study entry)ICS hypersensitivityalbuterol intoleranceuse of beta-blocker medication (oral and ophthalmic)use of systemic glucocorticosteroid medication within 6 wk prior to the screening visitan 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 productsOxygen (O2) saturation of <90% at-rest breathing room airLong-term oxygen therapy (LTOT) required at restregular use of pulmonary vasodilatorssystemic arterial systolic pressure >150 mmHg and diastolic pressure >100 mmHg on the test daya >40mmHg right ventricular systolic pressure (RVSP) by prior echocardiographya documented COVID infection within 4 weeks of the screening dayRegular use of home oxygen at restPhysician diagnosis of obesity hypoventilation syndrome
Source: ClinicalTrials.gov (NCT05607719). StuddyBuddy aggregates publicly available trial information.