NCT01031706

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

Completed NA Results posted Last updated 18 January 2017

What this trial tests

NA trial testing Hypertonic Saline in Cystic Fibrosis in 23 participants. Completed in 1 July 2012.

Timeline

1 September 2009

Primary endpoint
1 July 2012

1 July 2012

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	23
Start date	1 September 2009
Primary completion	1 July 2012
Estimated completion	1 July 2012
Sites	1 location across United States

Drugs / interventions tested

• Hypertonic Saline — full drug profile →
• Placebo

Conditions studied

• Cystic Fibrosis — all drugs for Cystic Fibrosis →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 5 to 12, any sex, with Cystic Fibrosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Mucociliary Clearance Rate
  Time frame: Baseline versus after completion of 4 week treatment period
  Average radio tracer clearance through 90 minutes (MCC90) is primary index of mucociliary clearance at each study. Primary study outcome: is absolute change in MCC90 between baseline and at end of treatment (where MCC measured 8-12 hours after final dose of study drug) - reflects sustained impact on MCC

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A four week trial of hypertonic saline in children with mild cystic fibrosis lung disease: Effect on mucociliary clearance and clinical outcomes.
   Donaldson SH, Danielle Samulski T, LaFave C, Zeman K, et al · · 2020 · cited 18× · PMID 32669217 · DOI 10.1016/j.jcf.2020.07.009