Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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 on a sub using a sub-sample to assess the lower airway inflammatory cells and markers in relation to new emerging organisms in cystic fibrosis (CF) and antibiotic therapy in CF.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children

Criteria

Inclusion Criteria:

1. Children diagnosed with CF (by sweat chloride ≥60 and/or genetic testing)

2. Children ages between 6-18 years

3. Ability to perform pulmonary function tests

4. FEV1 ≥ 30% predicted18.

Additional inclusion criteria for sub-sample undergoing antibiotic therapy:

1. Above criteria

2. Admitted to hospital for i.v. antibiotic therapy

Exclusion Criteria:

1. Acute respiratory distress or hypoxia (oxygen saturation <92% at room air)

2. New onset of wheezing

3. Previous history of intolerance of inhalation of HS