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NCT01031706 · ClinicalTrials.gov registry record · NA
Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT01031706: Completed NA study, sponsored by University of North Carolina, Chapel Hill.
NCT01031706 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01031706, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG Hypertonic Saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2009-09 |
| Est. Completion | 2012-07 |
| Phase | NA |
What the finished NCT01031706 record still lists
NCT01031706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01031706 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01031706 about?
NCT01031706 is a clinical study titled "Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis". 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 tha...
What is the current status of trial NCT01031706?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2009-09. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01031706?
The interventions under investigation include: Placebo (DRUG), Hypertonic Saline (DRUG).
Who is sponsoring clinical trial NCT01031706?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01031706's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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