Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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
ACTRN12610000561088
Ethics application status
Approved
Date submitted
5/07/2010
Date registered
12/07/2010
Date last updated
26/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
How do thick airway walls affect airway hyperresponsiveness in asthma.
Scientific title
Effect in asthmatic subjects of changes in airway wall thickness induced by inhaled corticosteroids on airway hyperresponsiveness
Secondary ID [1] 252157 0
National Health and Medical Research Council (NHMRC) Grant No: X08-0072
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 257701 0
Condition category
Condition code
Respiratory 257872 257872 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All subjects will be treated with fluticasone as inhaled combination therapy (Seretide) at 500ug twice daily (bd) for twelve weeks
Intervention code [1] 256756 0
Diagnosis / Prognosis
Intervention code [2] 256787 0
Treatment: Drugs
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258733 0
Change in airway wall thickness, measured using high resoution computed tomography (HRCT) scans, during 3 months treatment correlates with a change in airway responsiveness, measured using methacholine bronchial challenge tests.
Timepoint [1] 258733 0
after 3 months of treatment
Primary outcome [2] 258764 0
correlation between airway stiffness, measured using the forced oscillation technique, and airway responsiveness, measured using methacholine bronchial challenge tests
Timepoint [2] 258764 0
before and after 3 months of treatment
Secondary outcome [1] 264779 0
correlation between airway wall thickening, measured using high resoution computed tomography (HRCT) scans, and airway stiffness, measured using the forced oscillation technique.
Timepoint [1] 264779 0
before and after 3 months of treatment

Eligibility
Key inclusion criteria
doctor-diagnosed asthma; current symptoms of asthma; airway hyperresponsiveness to methacholine; taking no more than 800ug Beclomethasone diproprionate (BDP) equivalent/day;
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
current smokers within the last year or having more than 10 years pack history; pregnancy; history of lung cancer, lung reduction surgery, major illness (heart attack, stroke, epilepsy, rheumatoid arthritis); respiratory infection or oral pregnisolone use within the four weeks prior to study participation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Only one treatment intervention was used and this was only for those participants who were suitable for treatment (they had to have airway hyperresponsiveness and current symptoms and/or taking current treatment for their asthma)
Phase
Phase 4
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257248 0
Government body
Name [1] 257248 0
NHMRC
Country [1] 257248 0
Australia
Primary sponsor type
Other
Name
The Woolcock Institute of Medical Research
Address
431 Glebe Point Road
Glebe NSW 2037
Country
Australia
Secondary sponsor category [1] 256491 0
None
Name [1] 256491 0
Address [1] 256491 0
Country [1] 256491 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259269 0
Sydney South West Area Health Service
Ethics committee address [1] 259269 0
Locked Bag 7017
Liverpool NSW 1817
Ethics committee country [1] 259269 0
Australia
Date submitted for ethics approval [1] 259269 0
Approval date [1] 259269 0
03/06/2008
Ethics approval number [1] 259269 0
08/RPAH/121

Summary
Brief summary
Asthmatic airways narrow too easily, a characteristic called airway hyperresponsiveness (AHR). To understand the cause of asthma we need to understand the cause of AHR. Thickened airway walls could amplify airway narrowing and increase AHR. However, thick airway walls are also stiff, and stiff walls could reduce narrowing and AHR. This projnect will examine the relationships between AHR and airway wall thickness and stiffness during and after treatment that reduces airway wall thickness. Airway wall thickness will be measured by high-resolution computed tomography (HRCT) scan of the chest. Airway stiffness will be measured using a simple breathing test. Measurements will be made at baseline and after six and twelve weeks of treatment. Treatment with inhaled corticosteroids over twelve weeks will be used to reduce airway inflammation and airway wall thickness. These drugs are recommended in all asthma management guidelines for the treatment of asthma, and will be used in standard, recommended doses.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31365 0
Address 31365 0
Country 31365 0
Phone 31365 0
Fax 31365 0
Email 31365 0
Contact person for public queries
Name 14612 0
Dr Nathan Brown
Address 14612 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2050
Country 14612 0
Australia
Phone 14612 0
+61 2 9114 0147
Fax 14612 0
+61 2 9114 0014
Email 14612 0
[email protected]
Contact person for scientific queries
Name 5540 0
Dr Nathan Brown
Address 5540 0
Woolcock Institute of Medical Research
431 Glebe Point Road
Glebe NSW 2050
Country 5540 0
Australia
Phone 5540 0
+61 2 9114 0147
Fax 5540 0
+61 2 9114 0014
Email 5540 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.