Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

University of Miami

Status and phase: Enrolling; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Bretzri; Drug: Bevespi

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05607719

20220347

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Bretzri followed by Bevespi Group

Experimental group

Description:

Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.

Treatment:

Drug: Bevespi

Drug: Bretzri

Bevespi followed by Bretzri Group

Experimental group

Description:

Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.

Treatment:

Drug: Bevespi

Drug: Bretzri