A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

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, it has a future role in assessing novel therapeutics in the Cystic Fibrosis (CF) population. As such, determining if it can be used as a short term pharmacodynamic biomarker is paramount.

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

Details

• Lead Sponsor: The Hospital for Sick Children

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

• 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 Criteria:

• 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