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Completed

NCT Number: NCT00117208

Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Great Ormond Hospital for Children, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mannitol

Drug

400mg BD for 12 weeks

mannitol + pulmozyme

Drug

combination

Dornase alpha

Drug

2.5mg daily for 2 weeks

Other names: rhDNase, pulmozyme

Primary outcomes

  1. FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase

    Time frame: 12 weeks

Secondary outcomes

  1. to compare mannitol to rhDNase on FVC

    Time frame: 12 weeks

  2. to assess whether the effects of mannitol are additive to rhDNase

    Time frame: 12 weeks

  3. to demonstrate that mannitol does not cause deterioration in airway inflammation

    Time frame: 12 weeks

  4. to assess whether mannitol reduces the bacterial load in the lung

    Time frame: 12 weeks

  5. to assess whether the effects of mannitol are beneficial to quality of life

    Time frame: 12 weeks

  6. to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 4, 2005
Registry last updated
Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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