Clinical trial NCT00792714: Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients
Official title: Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cystic Fibrosis
Lead sponsor: Syntara
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 18
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Royal Children's Hospital
state: Victoria
city: Sheffield
country: United Kingdom
facility: Sheffield Children's Clinical Foundation
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
Study officials:
References: