Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The general objective of the study is to estimate the systemic pharmacokinetics of mannitol after single and multiple dosing of IDPM 400 mg to adult and paediatric cystic fibrosis patients.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharmaxis
• Treatments: Mannitol

Criteria

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.