Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the medium term efficacy and safety profile of inhaled mannitol, on its own and also as an additional therapy to rhDNase (pulmozyme). In particular, we will assess the impact on: lung function; airway inflammation; sputum microbiology; exacerbations; quality of life; adverse events; exercise tolerance; total costs of hospital and community care; and cost-effectiveness.

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

Details

• Lead Sponsor: Pharmaxis
• Treatments: Mannitol

Criteria

Inclusion Criteria:

• Known diagnosis of cystic fibrosis (sweat test or genotype)

• Of either gender

• Aged between 8 and 18 years

• Have a baseline FEV1 of <70% of the predicted normal value

• Currently taking rhDNase for at least 4 weeks

Exclusion Criteria:

• Currently active asthma, uncontrolled hypertension, colonised with Burkholderia cepacia or MRSA

• Listed for transplantation

• Known intolerance to mannitol, rhDNase or bronchodilators