Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

• Status: Not yet recruiting
• Trial end date: 2024-01-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Collaborator: AstraZeneca

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