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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/NCT00730977




Registration number
NCT00730977
Ethics application status
Date submitted
5/08/2008
Date registered
8/08/2008
Date last updated
18/09/2009

Titles & IDs
Public title
A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device
Scientific title
A Pilot Study to Investigate the Tolerability of Inhaled Dry Powder Mannitol (IDPM) Administered Via a Novel Dry Powder Inhaler Device in Healthy Individuals and Subjects With Bronchiectasis.
Secondary ID [1] 0 0
DPM-DEV-101b
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Bronchiectasis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - dry powder inhaled mannitol

Experimental: single - single arm, open label, 4 doses tested.


Treatment: Drugs: dry powder inhaled mannitol
single doses of 40 mg, 70 mg and 100 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
tolerability
Timepoint [1] 0 0
immediately and 10 mins post dose
Secondary outcome [1] 0 0
respiratory symptoms, FEV1
Timepoint [1] 0 0
pre-dose, immediately and 10 mins post dose

Eligibility
Key inclusion criteria
- healthy or bronchiectatic; 18 years and over
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- uncontrolled asthma, unstable

Study design
Purpose of the study
Allocation to intervention
N/A
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/Phase 2
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
1/08/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2008
Sample size
Target
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
A novel dry powder inhaler device will be used to administer mannitol to healthy subjects and
subjects with bronchiectasis in single doses higher than previously given.The main objective
is to assess tolerability of these doses using the new device.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00730977
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/NCT00730977