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Sponsored by: |
Pharmaxis |
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Information provided by: | Pharmaxis |
ClinicalTrials.gov Identifier: | NCT00117208 |
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.
Condition | Intervention | Phase |
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Cystic Fibrosis |
Drug: mannitol Drug: mannitol + pulmozyme Drug: Dornase alpha |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis |
Enrollment: | 20 |
Study Start Date: | November 2005 |
Study Completion Date: | February 2008 |
Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: mannitol
400mg BD for 12 weeks
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2: Active Comparator
DNase daily for 12 weeks
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Drug: Dornase alpha
2.5mg daily for 2 weeks
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3
combination
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Drug: mannitol + pulmozyme
combination
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Ages Eligible for Study: | 8 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Royal Brompton Hospital | |
London, United Kingdom | |
Great Ormond Hospital for Children | |
London, United Kingdom |
Principal Investigator: | Andrew Bush, FRCPCH | Royal Brompton and Harefiled NHS Trust |
Principal Investigator: | Colin Wallis, FRCPCH | Great Ormond Street Hospital for Children |
Study ID Numbers: | DPM-CF-203 |
Study First Received: | June 30, 2005 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00117208 History of Changes |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
cystic fibrosis |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Mannitol Fibrosis |
Lung Diseases Diuretics Infant, Newborn, Diseases Pancreatic Diseases Cardiovascular Agents |
Fibrosis Diuretics, Osmotic Physiological Effects of Drugs Diuretics Cardiovascular Agents Pharmacologic Actions Digestive System Diseases Pathologic Processes Cystic Fibrosis |
Respiratory Tract Diseases Genetic Diseases, Inborn Mannitol Natriuretic Agents Therapeutic Uses Lung Diseases Pancreatic Diseases Infant, Newborn, Diseases |