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NCT01355796 · ClinicalTrials.gov registry record · Phase 1

Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis

A Phase 1 study of Cystic Fibrosis, sponsored by Joseph Zabner.

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
2
Study locations

NCT01355796: Completed Phase 1 study of Cystic Fibrosis, sponsored by Joseph Zabner.

NCT01355796 is a Phase 1 study of Cystic Fibrosis that has completed, run by Joseph Zabner. The registered enrollment target is 30 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01355796, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Joseph Zabner.

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
2
Study locations

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 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

Primary Outcome

Change from baseline in FEV1(maximal amount of air you can forcefully exhale in one second) % predicted

Conditions Studied

Interventions

  • DRUG Hypertonic saline
  • DRUG Xylitol

Study Locations (2)

Illinois

  • Northwestern University - Chicago
  • Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2011-05
Est. Completion 2015-02
Phase Phase 1
Joseph Zabner

2 total trials

What the finished NCT01355796 record still lists

NCT01355796 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (83% lower).

The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Hypertonic saline is the first listed.

NCT01355796 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT01355796 about?

NCT01355796 is a clinical study titled "Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis". 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 NCT01355796?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2011-05. Estimated completion is 2015-02.

What conditions does trial NCT01355796 study?

This clinical trial studies the following conditions: Cystic Fibrosis.

What interventions are being tested in trial NCT01355796?

The interventions under investigation include: Hypertonic saline (DRUG), Xylitol (DRUG).

Who is sponsoring clinical trial NCT01355796?

This trial is sponsored by Joseph Zabner, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01355796 being conducted?

This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Cystic Fibrosis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01355796's enrollment target sits among peer trials

30 113th of 169 higher than 51 of 169 other Cystic Fibrosis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Cystic Fibrosis 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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Source: ClinicalTrials.gov NCT01355796, the US trial registry maintained by the National Library of Medicine. NCT01355796 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.