Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000225011
Ethics application status
Approved
Date submitted
15/03/2010
Date registered
17/03/2010
Date last updated
5/02/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Understanding asthma in older people
Scientific title
Is asthma in the elderly a disease of the peripheral airways? An observational study measuring airway hyperresponsiveness
Secondary ID [1] 1504 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 256971 0
Condition category
Condition code
Respiratory 257115 257115 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The predictors of airway hyperresponsiveness are being measured and compared with other measures of ventilation heterogeneity, lung elastic recoil, airway closure measured by lung imaging and lung volumes.
The study will last for 3 years, however each subject will complete 4 visits over 1-2 weeks.
Intervention code [1] 256148 0
Not applicable
Comparator / control treatment
No control.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258010 0
Airway hyperresponsiveness meaured using methacholine challenge
Timepoint [1] 258010 0
measured once only following clinical assessment for all participants
Secondary outcome [1] 263574 0
Nil
Timepoint [1] 263574 0
Nil

Eligibility
Key inclusion criteria
Doctor diagnosed asthmatics
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current smoking or history of smoking > 10 pack years, lung disease other than asthma, taking oral corticosteroids in last 4 weeks or having upper respiratory tract infection in last 4 weeks.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2010
Actual
9/02/2011
Date of last participant enrolment
Anticipated
Actual
19/07/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256652 0
Government body
Name [1] 256652 0
National Health and Medical Research Council
Country [1] 256652 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Woolcock Institute of Medical Research
Address
PO Box M77
Missenden Road Po
Camperdown
NSW 2050
Country
Australia
Secondary sponsor category [1] 255939 0
Hospital
Name [1] 255939 0
Dept of Respiratory Medicine, Royal North Shore Hospital
Address [1] 255939 0
Level 8, Royal North Shore Hospital,
Pacific Hwy,
St Leonards, NSW, 2065
Country [1] 255939 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258675 0
Northern Sydney Health Human Research Ethics Committee (Hawkesbury)
Ethics committee address [1] 258675 0
Level 2, Building 51,
Royal North Shore Hospital,
Pacific Hwy,
St Leonards, NSW, 2065
Ethics committee country [1] 258675 0
Australia
Date submitted for ethics approval [1] 258675 0
Approval date [1] 258675 0
15/03/2010
Ethics approval number [1] 258675 0
0912-333M (other)

Summary
Brief summary
Elderly asthmatics have poorer clinical outcomes compared with younger asthmatics. The reasons for this are unclear but may involve age-related changes in the disease itself. In this project we aim to show that asthma in the elderly is dominated by abnormalities of very small peripheral airways, in contrast to younger patients where the abnormalities occur in larger airways. The results will provide the basis for new and better targeted treatment strategies for asthma in the elderly.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30938 0
A/Prof Gregory King
Address 30938 0
Woolcock Institute of Medical Research, PO Box M77, Missenden Road PO, Camperdown, NSW, 2050 R
Country 30938 0
Australia
Phone 30938 0
+61 2 9926 6265
Fax 30938 0
Email 30938 0
[email protected]
Contact person for public queries
Name 14185 0
A/Prof Gregory King
Address 14185 0
Woolcock Institute of Medical Research,
PO Box M77,
Missenden Road PO,
Camperdown,
NSW, 2050
Country 14185 0
Australia
Phone 14185 0
+61 2 9926 6265
Fax 14185 0
Email 14185 0
[email protected]
Contact person for scientific queries
Name 5113 0
A/Prof Gregory King
Address 5113 0
Woolcock Institute of Medical Research,
PO Box M77,
Missenden Road PO,
Camperdown,
NSW, 2050
Country 5113 0
Australia
Phone 5113 0
+61 2 9926 6265
Fax 5113 0
Email 5113 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.