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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: Completed Phase 1 study, sponsored by University of Pittsburgh.
NCT00783107 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00783107 record still lists
NCT00783107 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00783107 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00783107's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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