Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

Completed · Phase 4

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT01745848

Run by

University of Pittsburgh

People needed

26

Starts

2013-02-01

Expected to finish

2016-06-30

Last updated by the study team

2017-08-29

Who can join

Age: 50 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Emphysema COPD Research Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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