Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Inclusion criteria

• Have given written informed consent to participate in this study in accordance with local regulations
• Have a confirmed diagnosis of cystic fibrosis (sweat test and/or genotype)
• Be aged >6 years (6-11 for paediatrics, 12-17 for adolescents and 18 years for adults)
• Have FEV1 > 30 % and < 90% predicted

Exclusion criteria

• Be investigators, site personnel directly affiliated with this study, or their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
• Be considered "terminally ill" or listed for lung transplantation
• Have had a lung transplant
• Be using nebulised hypertonic saline
• Have had a significant episode of haemoptysis (> 60 mL) in the three months prior to enrolment
• Have had a myocardial infarction in the three months prior to enrolment
• Have had a cerebral vascular accident in the three months prior to enrolment
• Have had major ocular surgery in the three months prior to enrolment
• Have had major abdominal, chest or brain surgery in the three months prior to enrolment
• Have a known cerebral, aortic or abdominal aneurysm
• Be breast feeding or pregnant, or plan to become pregnant while in the study
• Be using an unreliable form of contraception (female patients at risk of pregnancy only)
• Be participating in another investigative drug study, parallel to, or within 4 weeks of study entry (except inhaled mannitol)
• Not able to maintain a mannitol free diet from Day -2 until Day 8 of the treatment phase.
• Have a known allergy to mannitol
• Be using beta blockers
• Have uncontrolled hypertension - systolic blood pressure > 190 and / or diastolic blood pressure > 100
• Have a condition or be in a situation which in the Investigator's opinion may put the subject at significant risk, may confound results or may interfere significantly with the patient's participation in the study
• Be MTT positive.