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NCT00928135 · ClinicalTrials.gov registry record · Phase 1
Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects
A Phase 1 study, sponsored by Joseph Zabner.
- Completed
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
NCT00928135: Completed Phase 1 study, sponsored by Joseph Zabner.
NCT00928135 is a Phase 1 study that has completed, run by Joseph Zabner. The registered enrollment target is 63 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928135, a Phase 1 study, has completed, sponsored by Joseph Zabner.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
Study Summary
Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown to increase activity of salt sensitive antimicrobial peptides. Xylitol is a 5-carbon sugar that can lower the ASL salt concentration, thus enhancing innate immunity. In this study, the investigators propose to test the safety and tolerability of aerosolized xylitol used daily for 2 weeks in subjects with cystic fibrosis. In a pilot, 2-week study, 60 subjects with cystic fibrosis with an FEV1(Forced expiratory volume in 1 second ) \>30% predicted will be randomized to receive aerosolized 7% hypertonic saline (5 ml) or 15% xylitol, (5 ml) twice a day for 14 days. The primary outcomes will be safety as assessed by FEV1 change from baseline, adverse events and respiratory symptom score. Outcomes for trend in efficacy include density of colonization of sputum, time to next exacerbation, sputum cytokines and revised CF quality of life questionnaire.
Primary Outcome
Change in lung function (forced expiratory volume in 1 second) between baseline and Day 14
Interventions
- DRUG Hypertonic saline
- DRUG Xylitol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2013-01-22 |
| Est. Completion | 2018-04-09 |
| Phase | Phase 1 |
What the finished NCT00928135 record still lists
NCT00928135 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Hypertonic saline is the first listed.
NCT00928135 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00928135 about?
NCT00928135 is a clinical study titled "Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects". Cystic fibrosis (CF) lung disease is characterized by chronic bacterial colonization and recurrent infection of the airways. Lowering the airway surface liquid (ASL) salt concentration has been shown to increase activity of salt sensitive antimicrobial peptides. Xylitol is a 5-carbon sugar that can...
What is the current status of trial NCT00928135?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2013-01-22. Estimated completion is 2018-04-09.
What interventions are being tested in trial NCT00928135?
The interventions under investigation include: Hypertonic saline (DRUG), Xylitol (DRUG).
Who is sponsoring clinical trial NCT00928135?
This trial is sponsored by Joseph Zabner, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00928135's enrollment target sits among peer trials
63 820th of 2000 higher than 1,177 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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