Effects of inhaled corticosteroids on blood vessel function in COPD patients

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

This study is testing if adding inhaled corticosteroids to the treatment of stable COPD patients already using other medications can improve blood vessel function in their lungs.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: University of Miami (Academic / other)
• Locations: 1 site (Miami, Florida)
• Trial ID: NCT05607719 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the impact of adding inhaled corticosteroids (ICS) to the treatment regimen of stable COPD patients who are already on a combination of long-acting beta-agonists (LABA) and long-acting muscarinic antagonists (LAMA). Over a period of four weeks, researchers will assess whether this addition improves pulmonary vascular endothelial function, specifically measuring the vasodilator response to inhaled albuterol. The study will include patients aged 40-80 with a specific history of COPD and smoking. Participants must have been on a LABA/LAMA regimen for at least one month prior to enrollment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40-80 with a physician diagnosis of COPD and a history of significant smoking.

Not a fit: Patients who are currently using inhaled corticosteroids or have certain contraindications, such as recent respiratory infections or specific medication use, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for enhancing pulmonary function in COPD patients.

How similar studies have performed: While there is ongoing research in this area, the specific combination of ICS with LABA/LAMA in this context is relatively novel and has not been extensively tested.

Eligibility criteria

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

Where this trial is running

Miami, Florida

• University of Miami — Miami, Florida, United States (Recruiting)

Study contacts

• Principal investigator: Adam Wanner, MD — University of Miami
• Study coordinator: Adam Wanner, MD

Conditions Chronic Obstructive Pulmonary Disease