RECRUITING

Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-04-11

Study Completion:2025-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05607719

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.

Ages Eligible for Study:40 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Adam Wanner, MD

CONTACT

(305) 243-2568

awanner@med.miami.edu

Jennifer Biondo

CONTACT

(305) 243-2568

jnb184@miami.edu

Principal Investigator

Adam Wanner, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Adam Wanner, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-11

Study Completion Date2025-04-30

Study Record Updates

Study Start Date2023-04-11

Study Completion Date2025-04-30

Terms related to this study

Additional Relevant MeSH Terms

Chronic Obstructive Pulmonary Disease