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Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

NCT00117208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-02-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

mannitol

400mg BD for 12 weeks

DRUG

mannitol + pulmozyme

combination

DRUG

Dornase alpha

2.5mg daily for 2 weeks

Sponsors & Collaborators

  • Syntara

    lead INDUSTRY

Principal Investigators

  • Andrew Bush, FRCPCH · Royal Brompton and Harefiled NHS Trust

  • Colin Wallis, FRCPCH · Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2008-02-29
Completion
2008-02-29

Countries

  • United Kingdom

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 NCT00117208 on ClinicalTrials.gov