CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Hypertonic Saline +1 moredrug
Likely dose
Hypertonic Saline 4mLfrom 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/NCT01031706
NCT01031706N/ACompleted
CompareCT.gov

Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis

University of North Carolina, Chapel Hill·interventional·Posted Dec 15, 2009·Updated Mar 3, 2017

In Brief

A clinical study evaluating Hypertonic Saline and Placebo for Cystic Fibrosis. Completed, enrolled 23 participants across 1 site.

Detailed Summary

Previous work demonstrated that inhaled hypertonic saline (HS) reduces exacerbation frequency and improves lung function in adults with cystic fibrosis (CF). It is unclear, however, whether HS will benefit young patients suffering from CF. The investigators propose to further support the concept that HS can benefit children with mild CF lung disease by performing a relatively short, placebo controlled study of HS in 5-12 year olds, using lung function and mucociliary clearance as key outcome measures.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 15, 2009
Enrollment StartSep 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.5 years ago

Interventions

Hypertonic Salinedrug

inhaled HS (6% NaCl, 4mL) three times a day for 28 days

Placebodrug

4 ml 0.12% NaCl inhaled three times a day x 28 days