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NCT01745848 · ClinicalTrials.gov registry record · Phase 4
Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD
A Phase 4 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01745848: Completed Phase 4 study, sponsored by University of Pittsburgh.
NCT01745848 is a Phase 4 study that has completed, run by University of Pittsburgh. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01745848, a Phase 4 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study 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.
Primary Outcome
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 me
Interventions
- DRUG Roflumilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2013-02 |
| Est. Completion | 2016-06-30 |
| Phase | Phase 4 |
What the finished NCT01745848 record still lists
NCT01745848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which Roflumilast is the first listed.
NCT01745848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01745848 about?
NCT01745848 is a clinical study titled "Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD". 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.
What is the current status of trial NCT01745848?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2013-02. Estimated completion is 2016-06-30.
What interventions are being tested in trial NCT01745848?
The interventions under investigation include: Roflumilast (DRUG).
Who is sponsoring clinical trial NCT01745848?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01745848's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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