Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Study Overview
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Brief Summary
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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.

Official Title
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Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Drug: Mannitol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mannitol|400mg twice daily for 7 days|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 8 days |