Overview

The Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis

Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess whether rhDNase treatment improves ventilation inhomogeneity as assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
The Hospital for Sick Children
Criteria
Inclusion Criteria:

- Diagnosis of CF as defined by 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) has been provided by the subject's
parent or legal guardian and the subject

- 6-18 years of age at enrolment

- Able to perform reproducible spirometry

- Clinically stable at enrolment

- Ability to comply with medication use, study visits and study procedures as judged by
the site investigator

- FEV1 % predicted > 70 % as calculated by the Wang reference equations

Exclusion Criteria:

- Respiratory culture positive for:

- NTM within past year or AFB positive at screening (sputum only)

- B. cepacia complex within past year or at screening

- Use of intravenous antibiotics or oral quinolones within 14 days of screening

- Investigational drug use within 30 days of screening

- History of alcohol, illicit drug or medication abuse within 1 year of screening

- Other major organ dysfunction excluding pancreatic dysfunction

- History of lung transplantation or currently on lung transplant list

- Physical findings at screening that would compromise the safety of the participant or
the quality of the study data