Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease
Treatment roflumilast
Phase phase 4
Sponsor University of Pittsburgh
Start date February 2013
End date June 2016
Trial size 26 participants
Trial identifier NCT01745848, PRO12060615

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Roflumilast 500 μcg, once daily, for 30 days
roflumilast

Primary Outcomes

Measure
systemic markers of bone metabolism
time frame: 30 days

Secondary Outcomes

Measure
endothelial function
time frame: 30 days

Eligibility Criteria

Male or female participants from 50 years up to 70 years old.

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

Additional Information

Official title Effect of Roflumilast on Systemic Markers of Bone Metabolism and Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Pittsburgh.