Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Bretzri
- Registration Number
- NCT05607719
- Lead Sponsor
- University of Miami
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Bretzri followed by Bevespi Group Bretzri Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi. Bevespi followed by Bretzri Group Bretzri Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri. Bretzri followed by Bevespi Group Bevespi Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi. Bevespi followed by Bretzri Group Bevespi Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.
- Primary Outcome Measures
Name Time Method Albuterol induced percent change in pulmonary vascular resistance (PVR) baseline to 15 minutes post inhalation Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
- Secondary Outcome Measures
Name Time Method Albuterol induced absolute change in PVR baseline, up to 45 minutes post inhalation Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function
Change in oxygen saturation baseline, up to 45 minutes post inhalation Change in oxygen saturation measured by pulse oximetry
Percent change in FEV1 baseline to 15 minutes post inhalation Percent change in FEV1 will be measured using spirometry
Trial Locations
- Locations (1)
University of Miami
🇺🇸Miami, Florida, United States