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| Sponsor: | Pharmaxis |
|---|---|
| Information provided by: | Pharmaxis |
| ClinicalTrials.gov Identifier: | NCT00455130 |
Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| 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:
Contacts and Locations| 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 | |
| Greenlane Hospital | |
| Auckland, North Island, New Zealand | |
| Study Director: | Brett Charlton | Pharmaxis |
More Information
| ClinicalTrials.gov Identifier: | NCT00455130 History of Changes |
| Other Study ID Numbers: | DPM-CF-201 |
| Study First Received: | April 2, 2007 |
| Last Updated: | January 31, 2010 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration New Zealand: Medsafe |
|
mannitol cystic fibrosis mucolytic mucoactive |
|
Cystic Fibrosis Fibrosis Pancreatic Diseases Digestive System Diseases Lung Diseases Respiratory Tract Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Pathologic Processes |
Mannitol Diuretics, Osmotic Diuretics Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |