CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Xylitol +1 moredrug
Likely dose
Xylitol 5 mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01355796
NCT01355796Phase 2Completed
CompareCT.gov

Randomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic Fibrosis

Joseph Zabner·interventional·Posted May 18, 2011·Updated Oct 24, 2018

In Brief

A Phase 2 clinical trial evaluating Xylitol and Hypertonic saline for Cystic Fibrosis. Completed, enrolled 30 participants across 2 sites.

Detailed 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 plan to study the safety and efficacy of 2 weeks of inhaled xylitol compared to 2 weeks of hypertonic saline in a randomized crossover design in stable subjects with cystic fibrosis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsAnn & Robert H Lurie Children's Hospital of Chicago, Northwestern University

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 18, 2011
Enrollment StartMay 1, 2011
Primary CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.1 years ago

Interventions

Xylitoldrug

Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks

Hypertonic salinedrug

4 ml of 7 % saline aerosolized twice a day for 2 weeks