search
Back to results

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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Mannitol
Sponsored by
Pharmaxis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mater Adult Hospital
  • Royal Children's Hospital
  • Sheffield Children's Clinical Foundation
  • Southampton General Hospital

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
November 16, 2008
Last Updated
January 31, 2010
Sponsor
Pharmaxis
search

1. Study Identification

Unique Protocol Identification Number
NCT00792714
Brief Title
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients
Acronym
DPM-PK-102
Official Title
Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmaxis

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
400mg twice daily for 7 days
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Royal Children's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Sheffield Children's Clinical Foundation
City
Sheffield
ZIP/Postal Code
S102TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO166YD
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

We'll reach out to this number within 24 hrs