Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

NCT01745848 | Completed Phase 4 Results DMC

• 1 other identifier: PRO12060615
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Roflumilast; COPD

Outcome Measures

Primary Outcomes (1)

• Change From Baseline of Systemic Markers of Bone Metabolism (C-terminal Peptide of Type 1 Collagen (CTx) and Amino-terminal Propeptide of Type-1 Procollagen (P1NP))

  Serum samples were obtained at baseline and after participants took a once daily, 500 mcg roflumilast dose for 30 days. Samples were obtained in the semi-fasting state, processed, and stored for batch analysis at the end of the study. C-terminal peptide of type 1 collagen (CTx), a marker of bone resorption, was analyzed using a commercially available immunoassay (Roche Elecsys 2010 analyzer, Roche Diagnostics, Manheim, Germany). Serum amino-terminal propeptide of type-1 procollagen (P1NP) was measured by ELISA (MyBioSource, San Diego, CA). All assays were performed according to the manufacturers' instructions.

  30 days - measurements at baseline and 30 days

Secondary Outcomes (1)

• Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation

  30 days - measured at baseline and 30 days

Study Arms (1)

Study Drug

EXPERIMENTAL

Roflumilast 500 μcg, once daily, for 30 days

Drug: Roflumilast

Interventions

Roflumilast DRUG

Also known as: Daxas, Daliresp

Study Drug

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

Emphysema COPD Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Jessica Bon Field
• Organization: University of Pittsburgh

bonjm@upmc.edu

412-648-6494

Study Officials

• Jessica Bon Field, MD, MS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 10, 2012
• Study Start: February 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 30, 2016
• Last Updated: August 29, 2017
• Results First Posted: August 29, 2017

Record last verified: 2017-07

Locations

US (1)