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Sponsored by: |
Pharmaxis |
Information provided by: | Pharmaxis |
ClinicalTrials.gov Identifier: | NCT00455130 |
Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and reproductive organs. We know that many CF patients die of lung failure, brought about in part by repeated lung infections caused by thick, sticky mucus that cannot be readily cleared from the lung.
Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance, quality of life and lung function in CF and bronchiectasis. The promising results of these studies warrant futher investigation. The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF.
Condition | Intervention | Phase |
Cystic Fibrosis |
Drug: Inhaled mannitol |
Phase II |
Genetics Home Reference related topics: | cystic fibrosis |
MedlinePlus related topics: | Cystic Fibrosis |
Drug Information available for: | Mannitol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Ages Eligible for Study: | 8 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
As determined by the investigator, are capable and willing to
Exclusion Criteria:
Australia, New South Wales | |||||
Childrens Hospital at Westmead | |||||
Sydney, New South Wales, Australia, 2145 | |||||
Royal Prince Alfred Hospital | |||||
Sydney, New South Wales, Australia, 2050 | |||||
Australia, Queensland | |||||
Prince Charles Hospital | |||||
Brisbane, Queensland, Australia | |||||
Australia, Victoria | |||||
The Alfred Hospital | |||||
Melbourne, Victoria, Australia, 3181 | |||||
Royal Children's Hospital | |||||
Melbourne, Victoria, Australia, 3052 | |||||
Australia, Western Australia | |||||
Princess Margaret Hospital for Children | |||||
Perth, Western Australia, Australia, 6840 | |||||
Sir Charles Gairdner | |||||
Perth, Western Australia, Australia | |||||
New Zealand, North Island | |||||
Greenlane Hospital | |||||
Auckland, North Island, New Zealand |
Pharmaxis |
Study Director: | Brett Charlton | Pharmaxis |
Study ID Numbers: | DPM-CF-201 |
First Received: | April 2, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00455130 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; New Zealand: Medsafe |
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