CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 20 enrolled
Drug / intervention
hypertonic saline (7 %) and isotonic saline (0.9%) +1 moredrug
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/NCT00635141
NCT00635141Phase 3Completed
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The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis

The Hospital for Sick Children·interventional·Posted Mar 13, 2008·Updated Sep 2, 2013

In Brief

A Phase 3 clinical trial evaluating hypertonic saline (7 %) and isotonic saline (0.9%) for Cystic Fibrosis. Completed, enrolled 20 participants across 1 site.

Detailed Summary

This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis
CountriesCanada
CollaboratorsCanadian Cystic Fibrosis Foundation

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2008
Enrollment StartMar 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.3 years ago

Interventions

hypertonic saline (7 %) and isotonic saline (0.9%)drug

Patients in study arm 1 will receive hypertonic saline (7 %) during the first phase of the study and will crossover to placebo (0.9% isotonic saline) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.

hypertonic saline (7 %) and isotonic saline (0.9%)drug

Patients in study arm 2 will receive placebo (0.9% isotonic saline) during the first phase of the study and will crossover to hypertonic saline (7 %) during the second phase. Both drugs will be administered via PARI LC® Star reusable nebulizer.