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Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Information source: Pharmaxis
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cystic Fibrosis

Intervention: Mannitol (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Pharmaxis

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.

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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

Minimum age: 6 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Sheffield Children's Clinical Foundation, Sheffield S102TH, United Kingdom

Southampton General Hospital, Southampton SO166YD, United Kingdom

Mater Adult Hospital, Brisbane, Queensland 4101, Australia

Royal Children's Hospital, Melbourne, Victoria 3052, Australia

Additional Information

Starting date: December 2008
Last updated: January 31, 2010

Page last updated: August 23, 2015

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