Trial registered on ANZCTR


Trial ID
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
Gender
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
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Address [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