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The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis

NCT00635141 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-09-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

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

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.

DRUG

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

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.

Sponsors & Collaborators

  • Canadian Cystic Fibrosis Foundation

    collaborator OTHER

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Felix Ratjen, MD · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00635141 on ClinicalTrials.gov