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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Adam Wanner, MD
awanner@med.miami.edu
(305) 243-2568
Backup
Jennifer Biondo
jnb184@miami.edu
(305) 243-2568
Time Frame
Start Date: 2023-04-11
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 30
Treatments
Experimental: Bretzri followed by Bevespi Group
Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.
Experimental: Bevespi followed by Bretzri Group
Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.
Sponsors
Collaborators: AstraZeneca
Leads: University of Miami

This content was sourced from clinicaltrials.gov