Mannitol Dose Response Study in Cystic Fibrosis
Cystic Fibrosis
About this trial
This is an interventional treatment trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria: Diagnosis of cystic fibrosis (sweat test/genotype) 7 years or older FEV1 between 40% and 90% of predicted for height, age and gender. Able to perform acceptable-quality spirometry Clinically stable in the week up to study entry No additional antibiotics or additional oral steroids for a period of 14 days before study entry (routine antibiotics permitted) Exclusion Criteria Currently active asthma Subjects colonized with Burkholderia cepacia or MRSA Considered "terminally ill" or listed for transplantation Requiring home oxygen or assisted ventilation Concurrent illness that in the investigators opinion may contribute to an increased and unacceptable risk if the subject was enrolled in the study (e.g. significant varicies, portal hypertension, cor pulmonale) Significant episode of haemoptysis (>60 mLs) in the previous 12 months Heart attack or stroke in last 3 months Known aortic or cerebral aneurysm Subjects who are breast feeding or pregnant. At risk females unwilling to use appropriate contraception to prevent pregnancy during the course of the study Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry. Known intolerance to mannitol or unable to take any form of bronchodilator medications. Uncontrolled hypertension, systolic BP > 200 or diastolic BP> than 100 Concurrent use of beta blocker medication Concurrent use of hypertonic saline Canada: Concurrent use of other pharmacological mucolytic agents other than Pulmozyme Argentina: Concurrent use of other pharmacological mucolytic agents including Pulmozyme
Sites / Locations
- Hospital de Niños Superiora Sor María Ludovica
- Hospital Pediatrico
- Hospital Interzonal Especializado Materno Infantil (HIEMI)
- Hospital General de Niños
- Hospital Pediatrico Dr Humberto J Notti
- BC Children's Hospital
- St Pauls Hospital
- Janeway Children's Health and Rehabilitation Center
- Queen Elizabeth II Health Sciences Centre
- Hamilton Health Sciences Corporation
- The Hospital for Sick Children
- St Michaels Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
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2
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4