Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Mater Adult Hospital, Brisbane, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mannitol

Drug

400mg twice daily for 7 days

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Syntara

Industry

Registry information

Official study title

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

Acronym: DPM-PK-102

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Nov 18, 2008
Registry last updated: Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed