A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis

Inclusion criteria

• Confirmed diagnosis of cystic fibrosis (sweat test/genotype)
• Aged 8 years or older
• Have FEV1 between 40% and 80% of predicted for height, age and gender OR a decrease in FEV1 of 20% or more than that recorded 6-12 months previously.
• As determined by the investigator, are capable and willing to

• Use the study diary as required for this protocol
• Able to perform all of the techniques necessary to measure lung function
• Able to administer the dry powder mannitol
• Are capable of and have given informed consent
• Clinically stable at study entry

Exclusion criteria

• Investigators, site personnel directly affiliated with this study, and their immediate families.
• Subjects under the age of 8 years.
• Subjects with currently active asthma
• Subjects using hypertonic saline treatment in the last 2 weeks
• Considered "terminally ill" or listed for transplantation
• Requiring home oxygen or assisted ventilation
• Colonisation with Burkholderia cepacia
• Significant episode of hemoptysis (>60 mls) in the previous 12 months
• Myocardial Infarction in the six months prior to enrolment.
• Cerebral Vascular Accident in the six months prior to enrolment.
• Ocular surgery in the three months prior to enrolment.
• Abdominal surgery in the three months prior to enrolment.
• Subjects who are breast feeding or pregnant.
• Female subjects of reproductive capability, not using a reliable form of contraception
• Inability to obtain informed consent from the subject or subject's authorised representative.
• Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
• Known intolerance to mannitol or beta2 agonists.
• Uncontrolled hypertension - systolic BP > 160 and or diastoli