drugset / Trial / NCT02276898

A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index

NCT02276898

Phase 2 Completed 24 enrolled The Hospital for Sick Children
RandomizedCrossoverDouble-blindTreatment

Summary

The Lung Clearance Index (LCI) is a non invasive measure of lung function that is more sensitive than FEV1. It can be used to measure lung function in children younger than 6 years of age. Therefore, it has a future role in assessing novel therapeutics in the Cystic Fibrosis (CF) population. As such, determining if it can be used as a short term pharmacodynamic biomarker is paramount.

Timeline

Start
2011-11
Primary completion
2014-09
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator sodium chloride Unknown 4 ml Inhaled
Comparator sodium chloride Unknown 7 % Inhaled

Indications