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Sponsored by: |
Pharmaxis |
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Information provided by: | Pharmaxis |
ClinicalTrials.gov Identifier: | NCT00446680 |
The purpose of this study is to determine the efficacy and safety of chronic treatment with inhaled dry powder mannitol in subjects with cystic fibrosis. Previous studies have demonstrated an improvement in lung function related to small airways obstruction and a significant improvement in respiratory symptoms and quality of life after a 2 week treatment with mannitol. This current study seeks to support these early findings and to extend the evidence to support its use as a mucoactive therapy in cystic fibrosis. In particular, the hypothesis that enhanced mucus clearance will improve the lung function and clinical presentation in this population, will be investigated. We also hypothesize that enhanced mucociliary clearance will result in a sustained reduction in mucus load, thus providing less opportunity for bacteria to proliferate, affording a reduction in antibiotic use and hospitalizations. The initial 6 month blinded phase will be followed with an additional 6 months of open label treatment.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: Mannitol Drug: placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study |
Estimated Enrollment: | 340 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Mannitol
400mg BD for 6 months followed by a 6 month open label period
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2: Placebo Comparator |
Drug: placebo
placebo BD for 6 months
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Ages Eligible for Study: | 6 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main Inclusion Criteria:
Main Exclusion Criteria:
Australia, New South Wales | |
Childrens Hospital at Westmead | |
Sydney, New South Wales, Australia, 2145 | |
Sydney Childrens Hospital | |
Sydney, New South Wales, Australia | |
Australia, Queensland | |
Royal Brisbane Children's Hospital | |
Brisbane, Queensland, Australia, 4029 | |
The Prince Charles Hospital | |
Brisbane, Queensland, Australia, 4032 | |
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia | |
Australia, Victoria | |
Royal Childrens Hospital | |
Melbourne, Victoria, Australia, 3052 | |
Ireland | |
Beaumont Hospital | |
Dublin, Ireland | |
National Children's Hospital | |
Dublin, Ireland | |
Our Lady's Hospital for Sick Children | |
Dublin, Ireland | |
St Vincent's University Hospital | |
Dublin, Ireland | |
United Kingdom | |
Papworth Hospital | |
Cambridge, United Kingdom | |
Freeman Hospital | |
Newcastle, United Kingdom, NE7 7DN | |
The London Chest Hospital | |
London, United Kingdom, E2 9JX | |
Cardiothoracic Centre | |
Liverpool, United Kingdom, L14 3PE | |
Norfolk and Norwich University Hospital | |
Norwich, United Kingdom, NR4 7UY | |
Nottingham City Hospital | |
Nottingham, United Kingdom | |
Southampton General Hospital | |
Southampton, United Kingdom | |
Birmingham Heartlands Hospital | |
Birmingham, United Kingdom | |
Addenbrooke's Hospital | |
Cambridge, United Kingdom | |
Bristol Royal Infirmary | |
Bristol, United Kingdom | |
Bristol Royal Hospital for Children | |
Bristol, United Kingdom | |
Birmingham Children's Hospital | |
Birmingham, United Kingdom | |
Seacroft Hospital | |
Leeds, United Kingdom | |
Northern General Hospital | |
Sheffield, United Kingdom | |
Sheffield Children's Hospital | |
Sheffield, United Kingdom | |
United Kingdom, Liverpool | |
Alder Hey Children's Hospital | |
West Derby, Liverpool, United Kingdom | |
United Kingdom, Northern Ireland | |
Belfast City Hospital | |
Belfast, Northern Ireland, United Kingdom, BT9 7AB | |
United Kingdom, Wales | |
Children's Hospital for Wales | |
Cardiff, Wales, United Kingdom, CF14 4XW | |
Llandough Hospital | |
Cardiff, Wales, United Kingdom, CF64 2XX |
Study Director: | Brett Charlton, MBBS | Pharmaxis Ltd Australia |
Principal Investigator: | Dr Diana Bilton | Papworth Hospital Cambridge UK |
Principal Investigator: | Dr Philip Robinson | Royal Children's Hospital Melbourne Australia |
Responsible Party: | Pharmaxis Ltd ( Brett Charlton ) |
Study ID Numbers: | DPM-CF-301 |
Study First Received: | March 12, 2007 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00446680 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ireland: Ministry of Health; New Zealand: Medsafe |
Mannitol Cystic Fibrosis Mucolytic |
Exacerbation FEV1 Quality of Life |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Mannitol Fibrosis |
Lung Diseases Quality of Life Infant, Newborn, Diseases Pancreatic Diseases Cystic fibrosis |
Pathologic Processes Natriuretic Agents Therapeutic Uses Diuretics, Osmotic |
Physiological Effects of Drugs Diuretics Cardiovascular Agents Pharmacologic Actions |