Status:
COMPLETED
Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
6-18 years
Phase:
PHASE2
Brief Summary
The objective of the study is to evaluate the clinical utility and the feasibility, in an outpatient setting, of sputum induction using hypertonic saline. This study will also study pilot techniques o...
Detailed Description
Chronic airway infection, mainly by Staphylococcus aureus (SA) and Pseudomonas aeruginosa (PA), is a major cause of morbidity and mortality in patients with cystic fibrosis (CF). Isolation of organism...
Eligibility Criteria
Inclusion
- Children diagnosed with CF (by sweat chloride ≥60 and/or genetic testing)
- Children ages between 6-18 years
- Ability to perform pulmonary function tests
- FEV1 ≥ 30% predicted18.
- Additional inclusion criteria for sub-sample undergoing antibiotic therapy:
- Above criteria
- Admitted to hospital for i.v. antibiotic therapy
Exclusion
- Acute respiratory distress or hypoxia (oxygen saturation \<92% at room air)
- New onset of wheezing
- Previous history of intolerance of inhalation of HS
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT00721071
Start Date
December 1 2006
End Date
May 1 2008
Last Update
September 2 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8