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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bretzri followed by Bevespi Group | Experimental | Participants in this group will receive Bretzri for 4-weeks followed by 8-weeks of Bevespi. |
|
| Bevespi followed by Bretzri Group | Experimental | Participants in this group will receive Bevespi for 8-weeks followed by 4-weeks of Bretzri. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevespi | Drug | Two puffs twice a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Albuterol induced percent change in pulmonary vascular resistance (PVR) | Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function | baseline to 15 minutes post inhalation |
| Measure | Description | Time Frame |
|---|---|---|
| Albuterol induced absolute change in PVR | Echocardiographic assessment of PVR before and after inhalation of 180 μg albuterol as a test of endothelial function | baseline, up to 45 minutes post inhalation |
| Percent change in FEV1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam Wanner, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Bretzri | Drug | Two puffs twice a day |
|
Percent change in FEV1 will be measured using spirometry
| baseline to 15 minutes post inhalation |
| Change in oxygen saturation | Change in oxygen saturation measured by pulse oximetry | baseline, up to 45 minutes post inhalation |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |