Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Phase 1

Completed

• Conditions: Cystic Fibrosis

• Registration Number: NCT00792714
• Lead Sponsor: Syntara

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-16
• Study First Submitted QC: 2008-11-17
• Study First Posted: 2008-11-18
• Study Start: 2008-12
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2010-01
• Last Update Submitted: 2010-01-31
• Last Update Posted: 2010-02-02

Recruitment & Eligibility

• Status: COMPLETED
• 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 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	8 days

Trial Locations

Locations (4)

Southampton General Hospital; 🇬🇧 Southampton, United Kingdom

Sheffield Children's Clinical Foundation; 🇬🇧 Sheffield, United Kingdom

Mater Adult Hospital; 🇦🇺 Brisbane, Queensland, Australia

Royal Children's Hospital; 🇦🇺 Melbourne, Victoria, Australia