Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients (DPM-PK-102)

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00792714
First received: November 16, 2008
Last updated: January 31, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis
Drug: Mannitol
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 18
Study Start Date: December 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Mannitol
    400mg twice daily for 7 days
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00792714

Locations
Australia, Queensland
Mater Adult Hospital
Brisbane, Queensland, Australia, 4101
Australia, Victoria
Royal Children's Hospital
Melbourne, Victoria, Australia, 3052
United Kingdom
Sheffield Children's Clinical Foundation
Sheffield, United Kingdom, S102TH
Southampton General Hospital
Southampton, United Kingdom, SO166YD
Sponsors and Collaborators
Pharmaxis
  More Information

No publications provided

Responsible Party: Brett Charlton, Pharmaxis
ClinicalTrials.gov Identifier: NCT00792714     History of Changes
Other Study ID Numbers: DPM-PK-102
Study First Received: November 16, 2008
Last Updated: January 31, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Mannitol
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014