Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

Cystic Fibrosis Clinical Trial

— DPM-PK-102  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792714
• Other study ID #: DPM-PK-102
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2008
• Last updated: January 31, 2010
• Start date: December 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2010
• Source: Pharmaxis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• Mannitol
400mg twice daily for 7 days

Locations

Country	Name	City	State
Australia	Mater Adult Hospital	Brisbane	Queensland
Australia	Royal Children's Hospital	Melbourne	Victoria
United Kingdom	Sheffield Children's Clinical Foundation	Sheffield
United Kingdom	Southampton General Hospital	Southampton

Sponsors (1)

Lead Sponsor	Collaborator
Pharmaxis

Countries where clinical trial is conducted

Australia,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes