Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT01745848
- Phase
- PHASE4
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast — DRUG
Study Details
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.
Key Dates
- Start date
- Feb 28, 2013
- Status verified
- Jul 2017
- Primary completion
- Jun 30, 2016
- Completion
- Jun 30, 2016
Study Design
- Enrollment
- 26 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Study DrugRoflumilast 500 μcg, once daily, for 30 days
Primary Outcome Measure
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 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Emphysema COPD Research Center | Pittsburgh | Pennsylvania | 15213 | - |
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