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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00792714




Registration number
NCT00792714
Ethics application status
Date submitted
16/11/2008
Date registered
18/11/2008
Date last updated
2/02/2010

Titles & IDs
Public title
Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients
Scientific title
Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients
Secondary ID [1] 0 0
DPM-PK-102
Universal Trial Number (UTN)
Trial acronym
DPM-PK-102
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis 0 0
Condition category
Condition code
Human Genetics and Inherited Disorders 0 0 0 0
Cystic fibrosis
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Mannitol

Treatment: Drugs: Mannitol
400mg twice daily for 7 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
8 days

Eligibility
Key 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
Minimum age
6 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2009
Sample size
Target
18
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Mater Adult Hospital - Brisbane
Recruitment hospital [2] 0 0
Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
4101 - Brisbane
Recruitment postcode(s) [2] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Sheffield
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Syntara
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00792714
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00792714