Status:
COMPLETED
A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief 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, ...
Detailed Description
Inhaled Hypertonic saline (7%) is a treatment intervention for Cystic Fibrosis patients and has previously been shown to improve lung function and decrease the number of pulmonary exacerbations. The C...
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
- At least six years of age at enrolment
- Able to perform reproducible spirometry meeting American Thoracic Society standards
- Pre-bronchodilator FEV1 % predicted \> or equal to 40 % predicted
- Ability to perform a reproducible LCI maneuver at screening
Exclusion
- Known respiratory culture positive for Burkholderia cepacia
- Previous lung transplantation
- Use of intravenous antibiotics within 14 days of screening
- Use of oral antibiotics including prophylactic antibiotics (e.g., augmentin, tetracycline, cloxacillin, cephalosporins, septra, bactrim) within 14 days of screening
- Initiation of a new maintenance (e.g high dose ibuprofen, Pulmozyme®, aerosolized antibiotics) within 14 days of screening
- Use of systemic corticosteroids within 14 days of screening
- Investigational drug use within 30 days of screening
- Use of hypertonic saline (7%) \< 4 weeks before screening or outside of the study protocol
- Participation in any therapeutic clinical study \<4 weeks or, 5 half-lives, whichever is longer, before screening
- Smoking \< 3 months before screening
- Presence of a condition or abnormality that in the opinion of the site investigator would compromise the safety of the subject or the quality of the data
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02276898
Start Date
November 1 2011
End Date
September 1 2014
Last Update
May 22 2015
Active Locations (2)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5V1X8
2
St. Michaels Hospital
Toronto, Ontario, Canada