Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000482460
Ethics application status
Approved
Date submitted
5/09/2007
Date registered
21/09/2007
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of bronchodilators on lung ventilation in chronic obstructive pulmonary disease
Scientific title
The effect of tiotropium bromide on ventilation perfusion heterogeneity in 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 2337 0
Condition category
Condition code
Respiratory 2441 2441 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Washout period is one week between interventions.
Single dose of 18µg tiotropium bromide and 200µg salbutamol. Both drugs are inhaled
Intervention code [1] 2057 0
Treatment: Drugs
Comparator / control treatment
Placebo is 5.5mg lactose for Spiriva and propellant for Salbutamol
Control group
Placebo

Outcomes
Primary outcome [1] 3340 0
Primary Outcome 1: Ventilation perfusion before and after treatment
Timepoint [1] 3340 0
Timepoint: One hour after drug administration
Secondary outcome [1] 5557 0
Secondary Outcome 1: Ventilation heterogeneity measured using multiple breath nitrogen washout technique
Timepoint [1] 5557 0
Timepoint: One hour after drug administration

Eligibility
Key inclusion criteria
Subjects must have a doctor diagnosis of COPD, greater than 15pack year smoking history and obstructed lung function that cannot be normalised with bronchodilator. Subjects must all be over the age of 50 with no history of asthma or allergic disease.
Minimum age: 50 years for females and 40 years for males
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Females under the age of 50years

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)
Subjects are enrolled from our volunteer database and respiratory clinic. Allocation sequence kept by an independent researcher in a password protected file
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator in Microsoft excel used to determine treatment sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/08/2007
Actual
4/08/2007
Date of last participant enrolment
Anticipated
Actual
4/08/2008
Date of last data collection
Anticipated
Actual
4/08/2008
Sample size
Target
15
Accrual to date
Final
15
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 258 0
2050

Funding & Sponsors
Funding source category [1] 2594 0
Commercial sector/Industry
Name [1] 2594 0
Boehringer Ingelheim
Country [1] 2594 0
Germany
Funding source category [2] 2595 0
Other Collaborative groups
Name [2] 2595 0
CRC for asthma and airways
Country [2] 2595 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The Woolcock Institute of Medical Research
Address
Royal Prince Alfred Hospital
Level 3 Building 92
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 2347 0
None
Name [1] 2347 0
Address [1] 2347 0
Country [1] 2347 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4515 0
Northern Sydney central coast human research ethics committee
Ethics committee address [1] 4515 0
Ethics committee country [1] 4515 0
Australia
Date submitted for ethics approval [1] 4515 0
Approval date [1] 4515 0
13/04/2007
Ethics approval number [1] 4515 0
0512-232M(SP)

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

Contacts
Principal investigator
Name 28034 0
Address 28034 0
Country 28034 0
Phone 28034 0
Fax 28034 0
Email 28034 0
Contact person for public queries
Name 11191 0
Sarah Newton-John
Address 11191 0
PO Box M77 Missenden Rd
Camperdown NSW 2050
Country 11191 0
Australia
Phone 11191 0
61 2 9515 6578
Fax 11191 0
61 2 9550 5865
Email 11191 0
[email protected]
Contact person for scientific queries
Name 2119 0
Chantale Diba
Address 2119 0
PO Box M77 Missenden Rd
Camperdown NSW 2050
Country 2119 0
Australia
Phone 2119 0
61 2 9515 6175
Fax 2119 0
61 2 9550 6115
Email 2119 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.