Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients

• Conditions: Cystic Fibrosis; MedDRA version: 8.1Level: LLTClassification code 10011762Term: Cystic fibrosis

• Registration Number: EUCTR2008-008228-34-GB
• Lead Sponsor: Pharmaxis Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-29
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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 greater than or equal to 18 years for adults)
• Have FEV1 > 30 % and < 90% predicted
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified