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Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

S

Syntara

Status and phase

Completed
Phase 2

Conditions

Cystic Fibrosis

Treatments

Drug: mannitol + pulmozyme
Drug: mannitol
Drug: Dornase alpha

Study type

Interventional

Funder types

Industry

Identifiers

NCT00117208
DPM-CF-203

Details and patient eligibility

About

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.

Enrollment

20 patients

Sex

All

Ages

8 to 18 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

20 participants in 3 patient groups

1
Experimental group
Treatment:
Drug: mannitol
2
Active Comparator group
Description:
DNase daily for 12 weeks
Treatment:
Drug: Dornase alpha
3
Other group
Description:
combination
Treatment:
Drug: mannitol + pulmozyme

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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