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Trial registered on ANZCTR
Registration number
ACTRN12605000728639
Ethics application status
Approved
Date submitted
12/08/2005
Date registered
11/11/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered
Titles & IDs
Public title
Does tiotropium bromide lead to bronchodilation in cystic fibrosis ?
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Scientific title
Does tiotropium bromide lead to bronchodilation in cystic fibrosis ?
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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:
Cystic fibrosis
880
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Condition category
Condition code
Human Genetics and Inherited Disorders
948
948
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0
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Cystic fibrosis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
A single dose of inhaled tiotropium bromide with measurement of FEV1 over the following 24 hours. Then a 7 day 'washout' period follwed by cross-over to the alternate study arm and repeat
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Comparator / control treatment
Placebo with measurement of FEV1 over the following 24 hours. Then a 7 day 'washout' period follwed by cross-over to the alternate study arm and repeat
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Improvement in FEV1 by 10% or greater at any time within 24 hours of medication administration
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Assessment method [1]
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Timepoint [1]
1246
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Secondary outcome [1]
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Symptom improvement
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [2]
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Medication side-effects
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Assessment method [2]
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Timepoint [2]
2267
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Eligibility
Key inclusion criteria
Confirmed CF, stable disease ( no infective exacerbation for prior 2 weeks ).
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Minimum age
Not stated
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Maximum age
Not stated
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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
Recent infective exacerbation in prior 2 weeks, pregnant/breastfeeding.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Blinded by means of a sealed envelope with allocation performed by a hospital pharmacist not otherwise involve in the trial conduct
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomization
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Crossover
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Other design features
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Phase
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/07/2005
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Actual
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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
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Sample size
Target
14
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Self funded/Unfunded
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Name [1]
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Address [1]
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Country [1]
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Primary sponsor type
Hospital
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Name
Mater Adults Hospital, South Brisbane
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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nil
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Address [1]
907
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Country [1]
907
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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Trial website
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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
35551
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Contact person for public queries
Name
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Dr Greg Keir
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Address
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Mater Adults Hospital
Raymond Terrace
South Brisbane QLD 4101
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Country
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Australia
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Phone
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+61 7 3240 2111
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Greg Keir
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Address
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Mater Adults Hospital
Raymond Terrace
South Brisbane QLD 4101
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Country
294
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Australia
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Phone
294
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+61 7 3240 2111
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Fax
294
0
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Email
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[email protected]
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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
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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