Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00117208

Enrollment

Registered

2005-07-04

Start date

2005-11-30

Completion date

2008-02-29

Last updated

2010-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis

Brief 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.

Interventions

DRUGmannitol

400mg BD for 12 weeks

DRUGmannitol + pulmozyme

combination

DRUGDornase alpha

2.5mg daily for 2 weeks

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
FEV1 after 12 weeks of each of the following treatment regimens: mannitol only rhDNase only *mannitol + rhDNase	12 weeks

Secondary

Measure	Time frame
to assess whether the effects of mannitol are additive to rhDNase	12 weeks
to demonstrate that mannitol does not cause deterioration in airway inflammation	12 weeks
to compare mannitol to rhDNase on FVC	12 weeks
to assess whether the effects of mannitol are beneficial to quality of life	12 weeks
to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone	12 weeks
to assess whether mannitol reduces the bacterial load in the lung	12 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026