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Active (not recruiting) Phase 2 NCT05607719

Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Obstructive Pulmonary Disease

Sponsor: University of Miami

trial.available_in: БГ
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.
Who can participate
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
Interventions
Bevespi
DRUG
Bretzri
DRUG
Locations 1
United States (1)
University of Miami
Miami , Florida
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
11.04.2023
Completion date
30.06.2026
Registry ID
NCT05607719
Source
clinicaltrials.gov
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