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

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Canadian Cystic Fibrosis Foundation

Criteria

Inclusion Criteria:

• Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60 mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations

• Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject

• 6-18 years of age at enrolment and able to perform reproducible spirometry

• Clinically stable at enrolment

• FEV1 % predicted ≥ 80 % as calculated by the Wang reference equations

• Ability to comply with medication use, study visits and study procedures

Exclusion Criteria:

• Respiratory culture positive for NTM or B. cepacia complex within past year or screening

• Use of intravenous antibiotics or oral quinolones within 14 days of screening

• Investigational drug use within 30 days of screening

• Physical findings at screening that would compromise the safety of the participant or the quality of the study data