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OpenTrials
Active, Not Recruiting

NCT Number: NCT05607719

Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevespi

Drug

Two puffs twice a day

Bretzri

Drug

Two puffs twice a day

Primary outcomes

  1. Albuterol induced percent change in pulmonary vascular resistance (PVR)

    Time frame: 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 outcomes

  1. Albuterol induced absolute change in PVR

    Time frame: 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

  2. Percent change in FEV1

    Time frame: baseline to 15 minutes post inhalation

    Percent change in FEV1 will be measured using spirometry

  3. Change in oxygen saturation

    Time frame: baseline, up to 45 minutes post inhalation

    Change in oxygen saturation measured by pulse oximetry

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • AstraZeneca

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 7, 2022
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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