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Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis

NCT01355796 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2018-10-24

Study results available
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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

Conditions

Interventions

DRUG

Xylitol

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

DRUG

Hypertonic saline

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

Sponsors & Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • Northwestern University

    collaborator OTHER

  • Joseph Zabner

    lead OTHER

Principal Investigators

  • Joseph Zabner, MD · University of Iowa

  • Lakshmi Durairaj, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2015-02-28
Completion
2015-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01355796 on ClinicalTrials.gov