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NCT00974142 · ClinicalTrials.gov registry record · Phase 1
Oral Cyclosporine in Chronic Obstructive Pulmonary Disease
A Phase 1 study, sponsored by Michael Donahoe.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT00974142: Completed Phase 1 study, sponsored by Michael Donahoe.
NCT00974142 is a Phase 1 study that has completed, run by Michael Donahoe. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00974142, a Phase 1 study, has completed, sponsored by Michael Donahoe.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA) in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune response in advanced stage Chronic Obstructive Pulmonary Disease (COPD). Subjects between 45 and 80 years of age with a confirmed diagnosis of advanced stage COPD, not responsive to conventional inhaler therapy, who meet all the study requirements, will be enrolled in this study. A total of 30 subjects of either sex will be enrolled in this study.
Primary Outcome
Measurement of nephrotoxicity by monitoring serum creatinine over 16 week treatment interval. Mean serum creatinine values were assessed at Week 2, 4, 6, 8, 10, 12 and 16. The mean values of all measurements for each participant were calculated and then the mean across participants was calculated. Values expressed as mean ± SD.
Interventions
- DRUG Placebo
- DRUG Cyclosporine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2009-09 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
What the finished NCT00974142 record still lists
NCT00974142 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00974142 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00974142 about?
NCT00974142 is a clinical study titled "Oral Cyclosporine in Chronic Obstructive Pulmonary Disease". This is a randomized, double-blinded, placebo-controlled trial of oral Cyclosporine A (CsA) in patients with advanced stage chronic obstructive pulmonary disease. The purpose of the study is to evaluate the safety and effectiveness of CsA as a therapy for the adaptive immune response in advanced sta...
What is the current status of trial NCT00974142?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2009-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT00974142?
The interventions under investigation include: Placebo (DRUG), Cyclosporine (DRUG).
Who is sponsoring clinical trial NCT00974142?
This trial is sponsored by Michael Donahoe, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00974142's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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