University of Miami
Miami, Florida, 33136, United States
NCT Number: NCT05607719
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.
This study is active but is not currently recruiting participants.
40 year–80 year
All sexes
Interventional
Phase 2
Miami, Florida, 33136, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two puffs twice a day
Two puffs twice a day
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
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
Time frame: baseline to 15 minutes post inhalation
Percent change in FEV1 will be measured using spirometry
Time frame: baseline, up to 45 minutes post inhalation
Change in oxygen saturation measured by pulse oximetry
University of Miami
Other
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
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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