Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2009-09-30

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.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Mannitol

400mg twice daily for 7 days

Intervention Type DRUG

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.

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No