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Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD

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ClinicalTrials.gov Identifier: NCT01745848
Recruitment Status : Completed
First Posted : December 10, 2012
Results First Posted : August 29, 2017
Last Update Posted : August 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jessica Bon Field, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE December 6, 2012
First Posted Date  ICMJE December 10, 2012
Results First Submitted Date  ICMJE June 5, 2017
Results First Posted Date  ICMJE August 29, 2017
Last Update Posted Date August 29, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
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)) [ Time Frame: 30 days - measurements at baseline and 30 days ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
systemic markers of bone metabolism [ Time Frame: 30 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2017)
Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation [ Time Frame: 30 days - measured at baseline and 30 days ]
Participants had flow mediated dilation of the brachial artery measured at the baseline visit and at the follow-up visit after receiving 30 days of roflumilast 500 mcg daily. An ultrasound probe was placed over the brachial artery and the brachial artery diameter was measured in real time. A blood pressure cuff positioned below the elbow was then inflated to 50 mmHg above systolic pressure for five minutes. After five minutes of occlusion, the blood pressure cuff was released and the brachial artery diameter was again measured in real time. The amount of dilation expressed as the absolute change, in millimeters, from baseline diameter was quantified using the ultrasound images obtained 60 seconds after cuff release.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2012)
endothelial function [ Time Frame: 30 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Official Title  ICMJE Effect of Roflumilast on Systemic Markers of Bone Metabolism and Endothelial Function in Patients With Chronic Obstructive Pulmonary Disease
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
Open Label
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Drug: Roflumilast
Other Names:
  • Daxas
  • Daliresp
Study Arms  ICMJE Experimental: Study Drug
Roflumilast 500 μcg, once daily, for 30 days
Intervention: Drug: Roflumilast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2016)
26
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2012)
20
Actual Study Completion Date  ICMJE June 30, 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01745848
Other Study ID Numbers  ICMJE PRO12060615
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jessica Bon Field, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jessica Bon Field, MD, MS University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP