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NCT01094704 · ClinicalTrials.gov registry record · Phase 1
Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis
A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
NCT01094704: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.
NCT01094704 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01094704, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
Study Summary
Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed to inform exploratory clinical trial design in support of programs to develop new inhaled therapies for CF. We hypothesize that MCC/CC measurements can be used to determine the durability of action of agents like hypertonic saline (HS) which increase epithelial lining fluid height.
Primary Outcome
Duration of action of hypertonic saline as determined by measurements of mucociliary clearance/cough clearance 4 hours post dose.
Interventions
- DRUG sodium chloride (7%)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2009-11 |
| Est. Completion | 2010-05 |
| Phase | Phase 1 |
What the finished NCT01094704 record still lists
NCT01094704 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 1 intervention - of which sodium chloride (7%) is the first listed.
NCT01094704 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01094704 about?
NCT01094704 is a clinical study titled "Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis". Direct measurement of mucociliary and cough clearance (MCC/CC) has been used as a biomarker in cystic fibrosis (CF). Additional knowledge of the performance of this biomarker is needed to inform exploratory clinical trial design in support of programs to develop new inhaled therapies for CF. We hypo...
What is the current status of trial NCT01094704?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2009-11. Estimated completion is 2010-05.
What interventions are being tested in trial NCT01094704?
The interventions under investigation include: sodium chloride (7%) (DRUG).
Who is sponsoring clinical trial NCT01094704?
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 NCT01094704's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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