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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

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Intervention Drug: Roflumilast
Enrollment 26
Recruitment Details  
Pre-assignment Details All participants enrolled were assigned to the roflumilast group (no control arm of this study).
Arm/Group Title Roflumilast
Hide Arm/Group Description

Roflumilast 500 μcg, once daily, for 30 days

Roflumilast

Period Title: Overall Study
Started 26
Completed 20
Not Completed 6
Reason Not Completed
Adverse Event             6
Arm/Group Title Roflumilast
Hide Arm/Group Description Roflumilast 500 μcg, once daily, for 30 days
Overall Number of Baseline Participants 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants
65.3
(55 to 74)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
Female
12
  46.2%
Male
14
  53.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   7.7%
White
24
  92.3%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants
26
1.Primary Outcome
Title 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))
Hide Description 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.
Time Frame 30 days - measurements at baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.
Arm/Group Title Roflumilast
Hide Arm/Group Description:
Roflumilast 500 μcg, once daily, for 30 days
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: ng/mL
change in CTx levels from baseline to 30-days 0.079  (0.096)
change in P1NP levels from baseline to 30 days -101.77  (246.53)
2.Secondary Outcome
Title Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation
Hide Description 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.
Time Frame 30 days - measured at baseline and 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.
Arm/Group Title Roflumilast
Hide Arm/Group Description:
Roflumilast 500 μcg, once daily, for 30 days
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: millimeters
0.335  (4.63)
Time Frame 30 days for each participant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Roflumilast
Hide Arm/Group Description Roflumilast 500 μcg, once daily, for 30 days
All-Cause Mortality
Roflumilast
Affected / at Risk (%)
Total   0/26 (0.00%)    
Hide Serious Adverse Events
Roflumilast
Affected / at Risk (%) # Events
Total   0/26 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Roflumilast
Affected / at Risk (%) # Events
Total   6/26 (23.08%)    
Gastrointestinal disorders   
Gastrointestinal upset  [1]  3/26 (11.54%)  3
Gastrointestinal upset  [2]  3/26 (11.54%)  3
Indicates events were collected by systematic assessment
[1]
diarrhea after starting study drug
[2]
nausea
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jessica Bon Field
Organization: University of Pittsburgh
Phone: 412-648-6494
EMail: bonjm@upmc.edu
Layout table for additonal information
Responsible Party: Jessica Bon Field, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01745848    
Other Study ID Numbers: PRO12060615
First Submitted: December 6, 2012
First Posted: December 10, 2012
Results First Submitted: June 5, 2017
Results First Posted: August 29, 2017
Last Update Posted: August 29, 2017