Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000304639
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
6/09/2005
Date last updated
20/12/2018
Date data sharing statement initially provided
20/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Bronchodilator response in COPD: absent or wrong method of measurement?
Scientific title
Can a novel measure of acute bronchodilator responsiveness predict improvement in exercise capacity after four weeks treatment with tiotropium bromide in subjects with chronic obstructive pulmonary disease?
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease 392 0
Condition category
Condition code
Respiratory 464 464 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Salbutamol (200mcg), by metered dose inhaler, plus tiotropium bromide (18mcg), by dry powder inhaler, on one occasion, or placebo metered dose inhaler plus placebo capsule, by dry powder inhaler, on one occasion
Tiotropium bromide, 18mcg/day for four weeks, open label.
Intervention code [1] 297 0
None
Comparator / control treatment
Placebo metered dose inhaler plus placebo capsule
Control group
Placebo

Outcomes
Primary outcome [1] 525 0
Correlation between acute bronchodilator response and improvement in exercise capacity after four weeks treatment with tiotropium bromide
Timepoint [1] 525 0
Secondary outcome [1] 1127 0
Correlation between acute bronchodilator response and improvement in exertional dyspnea
Timepoint [1] 1127 0
After four weeks treatment with tiotropium bromide.

Eligibility
Key inclusion criteria
Moderate to severe chronic obstructive pulmonary disease, with FEV1 < 60% predicted and FEV1/FVC<70%
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Active and placebo drugs matched for appearance, prepared by independent researcher
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator in Microsoft Excel to determine sequence of treatment, no restrictions
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/01/2004
Actual
5/01/2004
Date of last participant enrolment
Anticipated
Actual
5/01/2005
Date of last data collection
Anticipated
Actual
5/01/2005
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 519 0
Other
Name [1] 519 0
Woolcock Institute of Medical Research
Country [1] 519 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 423 0
Other
Name [1] 423 0
Woolcock Institute of Medical Research
Address [1] 423 0
Country [1] 423 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1503 0
Sydney South West Area Health Service
Ethics committee address [1] 1503 0
Ethics committee country [1] 1503 0
Australia
Date submitted for ethics approval [1] 1503 0
05/10/2003
Approval date [1] 1503 0
05/10/2003
Ethics approval number [1] 1503 0

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

Contacts
Principal investigator
Name 35383 0
Address 35383 0
Country 35383 0
Phone 35383 0
Fax 35383 0
Email 35383 0
Contact person for public queries
Name 9486 0
Ms Wendy Taylor
Address 9486 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9486 0
Australia
Phone 9486 0
+61 2 95156578
Fax 9486 0
+61 2 95505865
Email 9486 0
[email protected]
Contact person for scientific queries
Name 414 0
Dr Cheryl Salome
Address 414 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 414 0
Australia
Phone 414 0
+61 2 95158383
Fax 414 0
+61 2 95506115
Email 414 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.