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Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

This study is not yet open for participant recruitment.
Verified December 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Jessica Bon, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01745848
First received: December 6, 2012
Last updated: December 7, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease
 Drug: Roflumilast
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Roflumilast on Systemic Markers of Bone Metabolism and Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:

Drug Information available for: Roflumilast
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • systemic markers of bone metabolism [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endothelial function [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Drug
Roflumilast 500 μcg, once daily, for 30 days
 Drug: Roflumilast

  Eligibility

Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745848

Contacts
Contact: Joseph Mastalski 412-683-7692 mastalskijp@upmc.edu

Locations
United States, Pennsylvania
Emphysema COPD Research Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Joseph Mastalski            
Sponsors and Collaborators
University of Pittsburgh
  More Information

No publications provided

Responsible Party: Jessica Bon, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01745848     History of Changes
Other Study ID Numbers: PRO12060615
Study First Received: December 6, 2012
Last Updated: December 7, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Roflumilast
COPD

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013