CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 12 enrolled
Drug / intervention
Hypertonic Salinedevice
Likely dose
Not stated in 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/NCT01617369
NCT01617369N/ACompleted

A Study to Characterize the Durability of Hypertonic Saline for the Enhancement of Mucociliary Clearance in Healthy Subjects

University of North Carolina, Chapel Hill·interventional·Posted Jun 12, 2012·Updated May 4, 2017

In Brief

A clinical study evaluating Hypertonic Saline for Healthy Subjects. Completed, enrolled 12 participants across 1 site.

Detailed Summary

The purpose of this research study is to learn about how long hypertonic saline (HS) works in healthy subjects. Inhaled hypertonic saline is one of the medications used to treat Cystic Fibrosis (CF). In CF and more common lung diseases like chronic bronchitis, mucus builds up in the lungs. Hypertonic saline and other medications currently being developed may help patients with these lung diseases by speeding up mucus clearance from the lung. For these treatments to be effective, they likely need to be able to act for at lease several hours. Investigators are able to measure how lung treatments like hypertonic saline work by conducting a Mucociliary Clearance (MCC) scan. Currently, the investigators do not know how long hypertonic saline works in people who do not have CF. Investigators plan to use this information to improve the design and testing of new treatments for patients with chronic bronchitis. Objectives: 1. The investigators will use MCC measurements to determine the durability of action of hypertonic saline in healthy (i.e. non-CF) subjects. 2. The investigators will determine the intra- and inter-individual variability of baseline MCC measurements using a slow inhalation/large particle protocol in healthy subjects to guide future sample size calculations.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGilead Sciences

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJun 12, 2012
Enrollment StartJun 1, 2012
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 14.1 years ago

Interventions

Hypertonic Salinedevice

2.8% NaCl x 4ml via nebulizer