Trial Outcomes & Findings for Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD (NCT NCT01745848)
NCT ID: NCT01745848
Last Updated: 2017-08-29
Results Overview
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.
COMPLETED
PHASE4
26 participants
30 days - measurements at baseline and 30 days
2017-08-29
Participant Flow
All participants enrolled were assigned to the roflumilast group (no control arm of this study).
Participant milestones
| Measure |
Roflumilast
Roflumilast 500 μcg, once daily, for 30 days
Roflumilast
|
|---|---|
|
Overall Study
STARTED
|
26
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Roflumilast
Roflumilast 500 μcg, once daily, for 30 days
Roflumilast
|
|---|---|
|
Overall Study
Adverse Event
|
6
|
Baseline Characteristics
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Baseline characteristics by cohort
| Measure |
Roflumilast
n=26 Participants
Roflumilast 500 μcg, once daily, for 30 days
|
|---|---|
|
Age, Continuous
|
65.3 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 30 days - measurements at baseline and 30 daysPopulation: Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.
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.
Outcome measures
| Measure |
Roflumilast
n=20 Participants
Roflumilast 500 μcg, once daily, for 30 days
|
|---|---|
|
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))
change in CTx levels from baseline to 30-days
|
0.079 ng/mL
Standard Deviation 0.096
|
|
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))
change in P1NP levels from baseline to 30 days
|
-101.77 ng/mL
Standard Deviation 246.53
|
SECONDARY outcome
Timeframe: 30 days - measured at baseline and 30 daysPopulation: Data were analyzed for the 20 participants completing baseline and follow-up visits after one month on study drug.
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.
Outcome measures
| Measure |
Roflumilast
n=20 Participants
Roflumilast 500 μcg, once daily, for 30 days
|
|---|---|
|
Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation
|
0.335 millimeters
Standard Deviation 4.63
|
Adverse Events
Roflumilast
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Roflumilast
n=26 participants at risk
Roflumilast 500 μcg, once daily, for 30 days
|
|---|---|
|
Gastrointestinal disorders
Gastrointestinal upset
|
11.5%
3/26 • Number of events 3 • 30 days for each participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place