Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country
Australia
Secondary sponsor category [1] 907 0
None
Name [1] 907 0
nil
Country [1] 907 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 35551 0
Address 35551 0
Country 35551 0
Phone 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
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
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.