Clinical Trial: Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With 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.

Detailed Summary:
Sponsor: Pharmaxis

Current Primary Outcome: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase [ Time Frame: 12 weeks ]

Original Primary Outcome: FEV1 after 12 weeks of each of the following treatment regimens: *mannitol only *rhDNase only *mannitol + rhDNase

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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


Information By: Pharmaxis

Dates:
Date Received: June 30, 2005
Date Started: November 2005
Date Completion:
Last Updated: January 31, 2010
Last Verified: January 2010