Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2005-10-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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1
mannitol
40 mg BD
2
mannitol
120mg BD
3
mannitol
240mg BD
4
mannitol
400mg BD
Interventions
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mannitol
120mg BD
mannitol
40 mg BD
mannitol
240mg BD
mannitol
400mg BD
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
7 Years
ALL
No
Sponsors
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Syntara
INDUSTRY
Responsible Party
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Pharmaxis Ltd
Principal Investigators
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Elizabeth Tullis, MD
Role: PRINCIPAL_INVESTIGATOR
St Michaels Hospital, Toronto, Ontario, Canada
Brett Charlton, MBBS PhD
Role: STUDY_DIRECTOR
Pharmaxis Ltd, Sydney, NSW, Australia
Locations
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Hospital de Niños Superiora Sor María Ludovica
La Plata, Buenos Aires, Argentina
Hospital Pediatrico
Resistencia, Chaco Province, Argentina
Hospital Interzonal Especializado Materno Infantil (HIEMI)
Buenos Aires, , Argentina
Hospital General de Niños
CABA, , Argentina
Hospital Pediatrico Dr Humberto J Notti
Mendoza, , Argentina
BC Children's Hospital
Vancouver, British Columbia, Canada
St Pauls Hospital
Vancouver, British Columbia, Canada
Janeway Children's Health and Rehabilitation Center
St. John's, Newfoundland and Labrador, Canada
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia, Canada
Hamilton Health Sciences Corporation
Hamilton, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
St Michaels Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DPM-CF-202
Identifier Type: -
Identifier Source: org_study_id