Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis P... | NCT00792714

Studies
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients

NCT00792714

Sponsor

Syntara

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

18Estimated

Phase

Phase 1

Conditions

Cystic Fibrosis

Interventions

Mannitol

Countries

Australia
United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2008

Primary Completion Date

Sep 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Nov 16, 2008

First Submission Date that Met QC Criteria

Nov 17, 2008

First Posted Date

Nov 18, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Estimated

Name	Type	Description	Arm Group Labels	Other Names
Mannitol	Drug	400mg twice daily for 7 days

Measure	Description	Time Frame
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 Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Mater Adult Hospital		Brisbane	Queensland	4101	Australia
Royal Children's Hospital

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D013402	Sugar Alcohols
D000438	Alcohols
D009930	Organic Chemicals
D002241	Carbohydrates