Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05607719
• Other study ID #: 20220347
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

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