Trial Review

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
ACTRN12605000317695
Ethics application status
Approved
Date submitted
29/08/2005
Date registered
6/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The clinical significance of heterogeneity in asthma
Scientific title
The clinical significance of ventilation heterogeneity in asthma, before and after 3 months of inhaled corticosteroid treatment
Universal Trial Number (UTN)
Trial acronym
02AU02-Bron trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 405 0
Condition category
Condition code
Respiratory 476 476 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Asthmatics were assigned to either Respocort or QVAR treatment for the duration of 3 months.
Intervention code [1] 295 0
None
Comparator / control treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 545 0
Ventilation heterogeneity
Timepoint [1] 545 0
Measured at baseline, and then at 1, 2 and 3 months during treatment.
Secondary outcome [1] 1154 0
Airway hyper-responsiveness
Timepoint [1] 1154 0
Measured at baseline, and then at 1, 2 and 3 months during treatment.
Secondary outcome [2] 1155 0
Exhaled nitric oxide
Timepoint [2] 1155 0
Measured at baseline, and then at 1, 2 and 3 months during treatment.
Secondary outcome [3] 1156 0
Lung function (spirometry and body plethysmography)
Timepoint [3] 1156 0
Measured at baseline, and then at 1, 2 and 3 months during treatment.
Secondary outcome [4] 1157 0
Respiratory system resistance
Timepoint [4] 1157 0
Measured at baseline, and then at 1, 2 and 3 months during treatment.
Secondary outcome [5] 1158 0
Cough sounds and respiratory symptoms.
Timepoint [5] 1158 0
Measured at baseline, and then at 1, 2 and 3 months during treatment.

Eligibility
Key inclusion criteria
Doctor-diagnosed asthma, with symptoms in the last 12 months.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smoking (in the last 6 months)* > 10 pack year history of smoking* Any other lung disease* Oral prednisone use in the last 4 weeks* Respiratory tract infection in the last 4 weeks.

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)
The sequence was concealed and allocated by hospital pharmacy.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random number sequence was generated by the random number generator in Microsoft Excel. The restriction method was by blocking.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/06/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
47
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 539 0
Other
Name [1] 539 0
CRC for Asthma
Country [1] 539 0
Australia
Primary sponsor type
Government body
Name
Central Sydney Area Health Service
Address
Country
Australia
Secondary sponsor category [1] 436 0
Other
Name [1] 436 0
Woolcock Institute of Medical Research
Address [1] 436 0
Country [1] 436 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1536 0
Royal Prince Alfred Hospital
Ethics committee address [1] 1536 0
Camperdown NSW 2050
Ethics committee country [1] 1536 0
Australia
Date submitted for ethics approval [1] 1536 0
Approval date [1] 1536 0
Ethics approval number [1] 1536 0

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

Contacts
Principal investigator
Name 35392 0
Address 35392 0
Country 35392 0
Phone 35392 0
Fax 35392 0
Email 35392 0
Contact person for public queries
Name 9484 0
Ms Wendy Taylor
Address 9484 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 9484 0
Australia
Phone 9484 0
+61 2 95156578
Fax 9484 0
+61 2 95505865
Email 9484 0
[email protected]
Contact person for scientific queries
Name 412 0
Ms Sue Downie
Address 412 0
PO Box M77
Missenden Road
Camperdown NSW 2050
Country 412 0
Australia
Phone 412 0
+61 2 95157524
Fax 412 0
+61 2 95506115
Email 412 0
[email protected]

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.