Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

NCT ID: NCT01745848

Last Updated: 2017-08-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2016-06-30

Brief 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.

Detailed Description

Study participants will be given Roflumilast 500 micrograms daily for 30 days. At baseline, prior to drug administration, blood samples will be collected for analysis of markers of bone metabolism (C-terminal telopeptide of Type I Collagen (CTx), Amino-terminal Propeptide of Type-1 Procollagen (P1NP) and participants will undergo measurement of endothelial function with measurement of brachial flow mediated dilation. After completion of one month of Roflumilast therapy, participants will have a repeat blood collection for measurement of CTx and P1NP and repeat measurement of brachial flow mediated dilation testing.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Drug

Roflumilast 500 μcg, once daily, for 30 days

Group Type: EXPERIMENTAL

Roflumilast

Intervention Type: DRUG

Interventions

Roflumilast

Intervention Type: DRUG

Other Intervention Names

Daxas; Daliresp

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jessica Bon Field

Assistant Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Bon Field, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

Emphysema COPD Research Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO12060615

Identifier Type: -

Identifier Source: org_study_id