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NCT00783107 · ClinicalTrials.gov registry record · Phase 1
Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT00783107 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 8 participants.
The verdict
NCT00783107, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of aerosolized Cyclosporine in treating COPD. The specific aims of the study are: 1. To identify the short term (28 day) safety profile of CyIS immunotherapy in severe COPD (GOLD III) patients with particular attention to airway reactivity and infection risk. 2. To identify the pharmacokinetic-pharmacodynamic relationship of CyIS using peripheral blood markers of an adaptive immune response as endpoints in subjects with severe COPD (GOLD III) treated short-term. Subjects between 45 and 70 years of age with a confirmed diagnosis of COPD, Gold Stage III, and meet all the study requirements, will be enrolled in this study. A total of 24 subjects of either sex will be enrolled in this study. A total of 4 subject cohorts (n=6) will participate in the protocol.
Interventions
- DRUG Placebo
- DRUG Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2007-10 |
| Est. Completion | 2009-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00783107
The ClinicalTrials.gov registry entry for NCT00783107 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00783107 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00783107 about?
NCT00783107 is a clinical study titled "Aerosol Cyclosporine in Chronic Obstructive Pulmonary Disease (COPD)". This is a randomized, double-blinded, Phase I dose escalation-deescalation protocol (DEP) of cyclosporine inhalation solution in patients with Gold Stage III chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of aerosolized Cyclosporine in tr...
What is the current status of trial NCT00783107?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2007-10. Estimated completion is 2009-09.
What interventions are being tested in trial NCT00783107?
The interventions under investigation include: Placebo (DRUG), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00783107?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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