Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01745848
• Other study ID #: PRO12060615
• Status: Active, not recruiting
• Phase: Phase 4
• First received: December 6, 2012
• Last updated: September 26, 2016
• Start date: February 2013
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Roflumilast

Locations

Country	Name	City	State
United States	Emphysema COPD Research Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	systemic markers of bone metabolism		30 days	No
Secondary	endothelial function		30 days	No