Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

NCT05607719 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: 20220347
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Albuterol induced absolute change in PVR

  baseline, up to 45 minutes post inhalation

• Percent change in FEV1

  baseline to 15 minutes post inhalation

• Change in oxygen saturation

  baseline, up to 45 minutes post inhalation

Study Arms (2)

Bretzri followed by Bevespi Group

EXPERIMENTAL

Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi.

Drug: Bevespi; Drug: Bretzri

Bevespi followed by Bretzri Group

EXPERIMENTAL

Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri.

Drug: Bevespi; Drug: Bretzri

Interventions

Bevespi DRUG

Two puffs twice a day

Bevespi followed by Bretzri Group; Bretzri followed by Bevespi Group

Bretzri DRUG

Two puffs twice a day

Bevespi followed by Bretzri Group; Bretzri followed by Bevespi Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead
• AstraZeneca: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adam Wanner, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 7, 2022
• Study Start: April 11, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)