Phase 4
N=26
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT01745848 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: 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)) — 0.079; -101.77 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Roflumilast (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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)) |
0.079; -101.77 | — |
| SECONDARY Absolute Change From Baseline of Measurements of Brachial Artery Flow Mediated Dilation |
0.335 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01745848). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.