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NCT00255242 · ClinicalTrials.gov registry record · Phase 1
Effect of Simvastatin on CF Airway Inflammation
A Phase 1 study, sponsored by Akron Children's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00255242: Completed Phase 1 study, sponsored by Akron Children's Hospital.
NCT00255242 is a Phase 1 study that has completed, run by Akron Children's Hospital. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00255242, a Phase 1 study, has completed, sponsored by Akron Children's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
Individuals with cystic fibrosis (CF) have persistent infection in the airways, which the body attempts to fight by recruiting immune cells (neutrophils) to the lung. The immune system and neutrophils are unable to completely kill the bacteria, and the response to the infection leads to inflammation (swelling) of the airways and lung damage. Nitric oxide (NO) has anti-bacterial and anti-inflammatory properties in the lung. NO production is decreased in CF patients, and may contribute to the persistent infection and inflammation. Increasing the production of NO in the airways of CF patients may help decrease this inflammation and infection. Rho GTPases are molecules in the cells that line the airways that decrease the protein that makes nitric oxide (NOS). Rho proteins also increase inflammation in these cells. Rho proteins are increased in CF cells, and may partially explain the low NO and high inflammation seen in CF. Blocking the Rho protein in CF cells increases NOS, which can then produce more NO. The Rho protein can be inhibited with a drug, simvastatin (Zocor®). Simvastatin is used by millions of people to lower their cholesterol, is very safe, has few side-effects and is approved for use in children greater than 10 years of age. We propose that treating CF patients with simvastatin will increase NO produced (exhaled NO), and may decrease airway inflammation. If simvastatin has these expected effects in CF, it would be another drug that has potential to become a new therapy to fight the debilitating lung damage of the disease.
Interventions
- DRUG Simvastatin treatment for 28 days
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-07 |
| Est. Completion | 2009-05 |
| Phase | Phase 1 |
What the finished NCT00255242 record still lists
NCT00255242 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Simvastatin treatment for 28 days is the first listed.
NCT00255242 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00255242 about?
NCT00255242 is a clinical study titled "Effect of Simvastatin on CF Airway Inflammation". Individuals with cystic fibrosis (CF) have persistent infection in the airways, which the body attempts to fight by recruiting immune cells (neutrophils) to the lung. The immune system and neutrophils are unable to completely kill the bacteria, and the response to the infection leads to inflammation...
What is the current status of trial NCT00255242?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-07. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00255242?
The interventions under investigation include: Simvastatin treatment for 28 days (DRUG).
Who is sponsoring clinical trial NCT00255242?
This trial is sponsored by Akron Children's Hospital, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00255242's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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