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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 is a Phase 1 study that has completed, run by Joseph Zabner. The registered enrollment target is 63 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00928135
The ClinicalTrials.gov registry entry for NCT00928135 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph Zabner, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Hypertonic saline is the first listed.
NCT00928135 reports 0 study locations.
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.
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