CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
sodium chloride (7%)drug
Likely dose
sodium chloride (7%) 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/NCT01094704
NCT01094704Phase 1Completed
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Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis

University of North Carolina, Chapel Hill·interventional·Posted Mar 29, 2010·Updated Aug 21, 2012

In Brief

A Phase 1 clinical trial evaluating sodium chloride (7%) for Cystic Fibrosis. Completed, enrolled 16 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesUnited States
CollaboratorsJohns Hopkins University, Novartis Pharmaceuticals

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 29, 2010
Enrollment StartNov 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.3 years ago

Interventions

sodium chloride (7%)drug

4mL nebulized 7% sodium chloride