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

Sponsor
Pharmaxis (Industry)
Overall Status
Completed
CT.gov ID
NCT00792714
Collaborator
(none)
18
Enrollment
4
Locations
9
Duration (Months)
4.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
18 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients
Study Start Date :
Dec 1, 2008
Actual Primary Completion Date :
Sep 1, 2009
Actual Study Completion Date :
Sep 1, 2009

Outcome Measures

Primary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Mater Adult Hospital Brisbane Queensland Australia 4101
2 Royal Children's Hospital Melbourne Victoria Australia 3052
3 Sheffield Children's Clinical Foundation Sheffield United Kingdom S102TH
4 Southampton General Hospital Southampton United Kingdom SO166YD

Sponsors and Collaborators

  • Pharmaxis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00792714
Other Study ID Numbers:
  • DPM-PK-102
First Posted:
Nov 18, 2008
Last Update Posted:
Feb 2, 2010
Last Verified:
Jan 1, 2010
Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Mannitol

Study Results

No Results Posted as of Feb 2, 2010