Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD



Status:Recruiting
Conditions:Chronic Obstructive Pulmonary Disease, Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:50 - 70
Updated:4/21/2016
Start Date:February 2013
End Date:March 2016
Contact:Joseph Mastalski
Email:mastalskijp@upmc.edu
Phone:412-683-7692

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Effect of Roflumilast on Systemic Markers of Bone Metabolism and Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease

Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease
surrogate markers of bone metabolism and early cardiovascular disease in individuals with
moderate to severe airflow obstruction and a chronic bronchitis phenotype.


Inclusion Criteria:

- Subjects between the ages of 50 and 70 with a minimum of ten-pack years of tobacco
exposure, airflow obstruction (FEV1/FVC < 0.70) with an FEV1 < 70%

- baseline sputum production at least some of the time as reported on the Saint
George's Respiratory Questionnaire, and at least one exacerbation within the past
year

Exclusion Criteria:

- Subjects with chronic prednisone use, antiresorptive therapy use (bisphosphonates,
calcitonin, parathyroid hormone)

- Subjects with a body mass index less than 18 or greater than 34
We found this trial at
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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