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
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Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
Jessica Bon Field, University of Pittsburgh
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Tracking Information | ||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
systemic markers of bone metabolism [ Time Frame: 30 days ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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.
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Original Secondary Outcome Measures ICMJE |
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
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Condition ICMJE | Chronic Obstructive Pulmonary Disease | |||
Intervention ICMJE | Drug: Roflumilast
Other Names:
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Study Arms ICMJE | Experimental: Study Drug
Roflumilast 500 μcg, once daily, for 30 days
Intervention: Drug: Roflumilast
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
26 | |||
Original Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |