Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Running, not enrolling · Phase 2

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT05607719

Run by

University of Miami

People needed

30

Starts

2023-04-11

Expected to finish

2026-07-31

Last updated by the study team

2026-06-22

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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