Chronic Obstructive Pulmonary Disease
Conditions
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.
Interventions
DRUGBevespi
Two puffs twice a day
DRUGBretzri
Two puffs twice a day
Sponsors
University of Miami
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Albuterol induced percent change in pulmonary vascular resistance (PVR) | 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
| Measure | Time frame | Description |
|---|---|---|
| Albuterol induced absolute change in PVR | 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 |
| Percent change in FEV1 | baseline to 15 minutes post inhalation | Percent change in FEV1 will be measured using spirometry |
| Change in oxygen saturation | baseline, up to 45 minutes post inhalation | Change in oxygen saturation measured by pulse oximetry |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAdam Wanner, MD
University of Miami
Outcome results
None listed