← Back to searchRecruitingRecruiting
Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
NCT05607719 · University of Miami
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
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
About this study
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.
Eligibility 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
Study design
Enrollment target: 30 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2023-04-11
Estimated completion: 2026-12-31
Last updated: 2026-01-09
Interventions
Drug: BevespiDrug: Bretzri
Primary outcomes
- • Albuterol induced percent change in pulmonary vascular resistance (PVR) (baseline to 15 minutes post inhalation)
Sponsor
University of Miami · other
With: AstraZeneca
Contacts & investigators
ContactAdam Wanner, MD · contact · awanner@med.miami.edu · (305) 243-2568
ContactJennifer Biondo · contact · jnb184@miami.edu · (305) 243-2568
InvestigatorAdam Wanner, MD · principal_investigator, University of Miami
All locations (1)
University of MiamiRecruiting
Miami, Florida, United States