NCT05607719CompletedPhase 2
Inhaled Corticosteroids (ICS) on Pulmonary Endothelial Function in COPD
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (actual)
- First submitted
- 2 Nov 2022
- Start date
- 11 Apr 2023
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- University of Miami
- Diseases
- COPD
- NCT number
- NCT05607719
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 25
- From 11 Apr 2023 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- a Corona Virus Disease (COVID) vaccination \<3 months prior to study entry
- 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)
- Long-term oxygen therapy (LTOT) required at rest
- a \>40mmHg right ventricular systolic pressure (RVSP) by prior echocardiography
Other illness
- respiratory infection within 4 weeks of a test day
- ICS hypersensitivity
- a documented COVID infection within 4 weeks of the screening day
- Physician diagnosis of obesity hypoventilation syndrome
Other
- women of childbearing potential who do not use accepted birth- control measures
- pregnant and breast-feeding women
- ICS use (within 4 weeks of study entry)
- albuterol intolerance
- current smoking or vaping tobacco or other products
- Oxygen (O2) saturation of \<90% at-rest breathing room air
- regular use of pulmonary vasodilators
- systemic arterial systolic pressure \>150 mmHg and diastolic pressure \>100 mmHg on the test day
- Regular use of home oxygen at rest
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.