Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

NCT00792714 | Completed Phase 1

• 1 other identifier: DPM-PK-102
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 4

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (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

Interventions

Mannitol DRUG

400mg twice daily for 7 days

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Syntara: lead

Study Sites (4)

Mater Adult Hospital

Brisbane, Queensland, 4101, Australia

Location

Royal Children's Hospital

Melbourne, Victoria, 3052, Australia

Location

Sheffield Children's Clinical Foundation

Sheffield, S102TH, United Kingdom

Location

Southampton General Hospital

Southampton, SO166YD, United Kingdom

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Mannitol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 16, 2008
• First Posted: November 18, 2008
• Study Start: December 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: February 2, 2010

Record last verified: 2010-01

Locations

GB (2); AU (2)