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Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00117208
First Posted: July 4, 2005
Last Update Posted: February 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pharmaxis
June 30, 2005
July 4, 2005
February 2, 2010
November 2005
February 2008   (Final data collection date for primary outcome measure)
FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase [ Time Frame: 12 weeks ]
FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase
Complete list of historical versions of study NCT00117208 on ClinicalTrials.gov Archive Site
  • to compare mannitol to rhDNase on FVC [ Time Frame: 12 weeks ]
  • to assess whether the effects of mannitol are additive to rhDNase [ Time Frame: 12 weeks ]
  • to demonstrate that mannitol does not cause deterioration in airway inflammation [ Time Frame: 12 weeks ]
  • to assess whether mannitol reduces the bacterial load in the lung [ Time Frame: 12 weeks ]
  • to assess whether the effects of mannitol are beneficial to quality of life [ Time Frame: 12 weeks ]
  • to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone [ Time Frame: 12 weeks ]
  • to compare mannitol to rhDNase on FVC
  • to assess whether the effects of mannitol are additive to rhDNase
  • to demonstrate that mannitol does not cause deterioration in airway inflammation
  • to assess whether mannitol reduces the bacterial load in the lung
  • to assess whether the effects of mannitol are beneficial to quality of life
  • to assess whether mannitol, or mannitol + rhDNase are cost-effective compared to rhDNase alone
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Cystic Fibrosis
  • Drug: mannitol
    400mg BD for 12 weeks
  • Drug: mannitol + pulmozyme
    combination
  • Drug: Dornase alpha
    2.5mg daily for 2 weeks
    Other Name: rhDNase, pulmozyme
  • Experimental: 1
    Intervention: Drug: mannitol
  • Active Comparator: 2
    DNase daily for 12 weeks
    Intervention: Drug: Dornase alpha
  • 3
    combination
    Intervention: Drug: mannitol + pulmozyme

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2008
February 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
8 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00117208
DPM-CF-203
Not Provided
Not Provided
Not Provided
Not Provided
Pharmaxis
Not Provided
Principal Investigator: Andrew Bush, FRCPCH Royal Brompton and Harefiled NHS Trust
Principal Investigator: Colin Wallis, FRCPCH Great Ormond Street Hospital for Children NHS Foundation Trust
Pharmaxis
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP