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

NCT00557089 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2013-09-02

No results posted yet for this study

Summary

This study will assess whether rhDNase treatment improves ventilation inhomogeneity as assessed by lung clearance index (LCI) in patients with cystic fibrosis (CF).

Conditions

Interventions

DRUG

rhDNAse

2.5 mg rhDNase will be dispensed in 2.5 ml vials and administered once a day for 28 days. Treatment will be administered by inhalation.

OTHER

Placebo

2.5 mg of the placebo will be dispensed in 2.5 ml vials and administered once a day over 28 days. Treatment will be administered by inhalation.

Sponsors & Collaborators

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Felix Ratjen, MD · The Hospital for Sick Children, Toronto Canada

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00557089 on ClinicalTrials.gov