Trial Review

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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 ?
Scientific title
Does tiotropium bromide lead to bronchodilation in cystic fibrosis ?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cystic fibrosis 880 0
Condition category
Condition code
Human Genetics and Inherited Disorders 948 948 0 0
Cystic fibrosis

Intervention/exposure
Study type
Interventional
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
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
Control group
Placebo

Outcomes
Primary outcome [1] 1246 0
Improvement in FEV1 by 10% or greater at any time within 24 hours of medication administration
Timepoint [1] 1246 0
Secondary outcome [1] 2266 0
Symptom improvement
Timepoint [1] 2266 0
Secondary outcome [2] 2267 0
Medication side-effects
Timepoint [2] 2267 0

Eligibility
Key inclusion criteria
Confirmed CF, stable disease ( no infective exacerbation for prior 2 weeks ).
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Recent infective exacerbation in prior 2 weeks, pregnant/breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated block randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1045 0
Self funded/Unfunded
Name [1] 1045 0
Country [1] 1045 0
Primary sponsor type
Hospital
Name
Mater Adults Hospital, South Brisbane
Address
Country
Australia
Secondary sponsor category [1] 907 0
None
Name [1] 907 0
nil
Address [1] 907 0
Country [1] 907 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35551 0
Address 35551 0
Country 35551 0
Phone 35551 0
Fax 35551 0
Email 35551 0
Contact person for public queries
Name 9366 0
Dr Greg Keir
Address 9366 0
Mater Adults Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 9366 0
Australia
Phone 9366 0
+61 7 3240 2111
Fax 9366 0
Email 9366 0
greg_keir@health.qld.gov.au
Contact person for scientific queries
Name 294 0
Dr Greg Keir
Address 294 0
Mater Adults Hospital
Raymond Terrace
South Brisbane QLD 4101
Country 294 0
Australia
Phone 294 0
+61 7 3240 2111
Fax 294 0
Email 294 0
greg_keir@health.qld.gov.au

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.