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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00656565
Registration number
NCT00656565
Ethics application status
Date submitted
7/04/2008
Date registered
11/04/2008
Date last updated
6/08/2008
Titles & IDs
Public title
Inspiratory Flow and Volumes in Bronchiectatics
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Scientific title
Inspiratory Flow Rates and Volumes in Subjects With Bronchiectasis Using Low and High Resistance Dry Powder Inhaler Devices
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Secondary ID [1]
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DPM-OSM-402
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
1 - subjects with bronchiectasis
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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inspiratory flow
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Assessment method [1]
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Timepoint [1]
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single visit
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Secondary outcome [1]
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inspiratory volume
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Assessment method [1]
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Timepoint [1]
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single visit
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Eligibility
Key inclusion criteria
* non-cf bronchiectasis
* aged 18-80 inclusive
* FEV1 greater or equal to 50% predicted and greater or equal to 1L
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Minimum age
18
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* uncontrolled asthma
* CF bronchiectasis
* have any condition for which spirometry measurement would be contraindicated
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/06/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2008
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Sample size
Target
15
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Syntara
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Adequate administration of drugs via dry powder inhalers is dependent on adequate inspiratory flow rates and volumes. These vary according to the device being used and its resistance. The dry powder inhaler device under investigation is a device approved by the Therapeutic Goods Administration (ARTG no. 196255) for use with dry powder mannitol. Dry powder mannitol is currently being investigated as a treatment for bronchiectasis. We wish to measure the inspiratory flow characteristics of both the low and high resistance devices amongst a group of subjects with bronchiectasis. We propose that the majority of subjects investigated with varying lung function will achieve adequate flow during a controlled inspiration.
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Trial website
https://clinicaltrials.gov/study/NCT00656565
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00656565
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