Mannitol Dose Response Study in Cystic Fibrosis

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