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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/NCT01076491




Registration number
NCT01076491
Ethics application status
Date submitted
11/11/2009
Date registered
26/02/2010
Date last updated
26/02/2010

Titles & IDs
Public title
High Dose Inhaled Mannitol Study
Scientific title
A Pilot Study to Investigate the Feasibility and Tolerability of Inhaling a High Dose of Dry Powder Mannitol (IDPM) Per Breath Administered Via a Dry Powder Inhaler Loaded With a Single Capsule in Subjects With Bronchiectasis
Secondary ID [1] 0 0
DPM-DEV-102b
Secondary ID [2] 0 0
DPM-DEV-102b
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - mannitol

Treatment: Drugs: mannitol
inhaled mannitol - single doses of either 70 mg or 90 mg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
emitted dose
Timepoint [1] 0 0
single measure

Eligibility
Key inclusion criteria
- adult subjects with non-CF bronchiectasis

- FEV1 > 50 % predicted and > 1.0L
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- bronchiectasis due to CF or endobronchial lesion

- respiratory infection requiring IV antibiotics in last 4 weeks

- pregnancy

- significant haemoptysis in last 6 months

- active TB

- end stage ILD

- contraindications as determined by investigator

Study design
Purpose of the study
Allocation to intervention
Randomised controlled 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/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
1/01/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2009
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Sydney
Recruitment postcode(s) [1] 0 0
2050 - Sydney

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

Ethics approval
Ethics application status

Summary
Brief summary
This study is to investigate the safety and tolerability of high doses of inhaled mannitol in
subjects with bronchiectasis to further direct development of an improved drug delivery
system.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01076491
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/NCT01076491