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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05607719
Other study ID # 20220347
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 11, 2023
Est. completion date April 30, 2025

Study information

Verified date December 2023
Source University of Miami
Contact Adam Wanner, MD
Phone (305) 243-2568
Email awanner@med.miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date April 30, 2025
Est. primary completion date January 31, 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Bevespi
Two puffs twice a day
Bretzri
Two puffs twice a day

Locations

Country Name City State
United States University of Miami Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Albuterol induced percent change in pulmonary vascular resistance (PVR) Echocardiographic assessment of PVR before and after inhalation of 180 µg albuterol as a test of endothelial function baseline to 15 minutes post inhalation
Secondary Albuterol induced absolute change in PVR Echocardiographic assessment of PVR before and after inhalation of 180 µg albuterol as a test of endothelial function baseline, up to 45 minutes post inhalation
Secondary Percent change in FEV1 Percent change in FEV1 will be measured using spirometry baseline to 15 minutes post inhalation
Secondary Change in oxygen saturation Change in oxygen saturation measured by pulse oximetry baseline, up to 45 minutes post inhalation
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