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Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

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

NCT01745848•University of Pittsburgh

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - 75 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Emphysema COPD Research Center

Pittsburgh, Pennsylvania, United States

Key Dates

Start Date

February 1, 2013

Primary Completion Date

June 1, 2016

Completion Date

June 30, 2016

Last Updated

August 29, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Roflumilast

DRUG

cfMSC Stem Cell Therapy Targeting COPD

NCT07477600

Chronic Obstructive Pulmonary Disease (COPD)

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RECRUITINGPHASE3

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT05878769

Chronic Obstructive Pulmonary Disease

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RECRUITINGNA

Probiotics in Pulmonaty Rehabilitation for COPD

NCT06717659

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 29, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

Inclusion Criteria

Exclusion Criteria

cfMSC Stem Cell Therapy Targeting COPD

A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Probiotics in Pulmonaty Rehabilitation for COPD

A Cohort for Inflammatory Respiratory Diseases: From Phenotyping to Personalised Medicine

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