Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00792714
• Date of registration: 16/11/2008
• Prospective Registration: Yes
• Primary sponsor: Pharmaxis
• Public title: Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients DPM-PK-102
• Scientific title: Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients
• Date of first enrolment: December 2008
• Target sample size: 18
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00792714
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Australia, United Kingdom

Key inclusion & exclusion 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.



Age minimum: 6 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: Mannitol

Primary Outcome(s)

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. [Time Frame: 8 days]

Secondary ID(s)

DPM-PK-102

Source(s) of Monetary Support

Please refer to primary and secondary sponsors