Status:
COMPLETED
The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Canadian Cystic Fibrosis Foundation
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
This study is examining the effect of hypertonic saline compared to placebo on the Lung Clearance Index in Cystic Fibrosis patients.
Detailed Description
The life expectancy of patients with Cystic Fibrosis (CF) has greatly increased over time due to improved clinical care. While this is certainly beneficial to CF patients, the overall stability in lun...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00635141
Start Date
March 1 2008
End Date
December 1 2008
Last Update
September 2 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada