Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Description

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.

Conditions

Chronic Obstructive Pulmonary Disease

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

The Effect of Inhaled Corticosteroids (ICS) Adjunct Therapy on Pulmonary Vascular Endothelial Function in Chronic Obstructive Pulmonary Disease (COPD): Comparison of Two Standard Treatments (NCT05607719

Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Condition
Chronic Obstructive Pulmonary Disease
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Adam Wanner, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2025-04-30