Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000414516
Ethics application status
Approved
Date submitted
5/09/2006
Date registered
21/09/2006
Date last updated
14/12/2018
Date data sharing statement initially provided
14/12/2018
Date results information initially provided
14/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Airway disease in older people
Scientific title
Does ventilation heterogeneity predict airway hyperresponsiveness in asthmatic and COPD patients aged over 50 years?
Universal Trial Number (UTN)
Trial acronym
06AsCOPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma in older people 1382 0
Chronic Obstructive Pulmonary Disease (COPD) in older people 1383 0
Condition category
Condition code
Respiratory 1474 1474 0 0
Asthma
Respiratory 1475 1475 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Ventilation heterogeneity and airway hyperresponsiveness are both observed on the same day in the one study visit (duration 2 hours) in asthmatic and COPD patients.
Intervention code [1] 1344 0
None
Comparator / control treatment
No comparator.
Control group

Outcomes
Primary outcome [1] 2042 0
Conducting airway ventilation heterogeneity are assessed on each patient
Timepoint [1] 2042 0
Ventilation heterogeneity is measured at the start of the visit
Primary outcome [2] 2043 0
Dose response ratio to methacholine challenge test assessed on each patient
Timepoint [2] 2043 0
The methacholine challenge test is conducted immediately after the ventilation heterogeneity is measured
Secondary outcome [1] 3527 0
NIL
Timepoint [1] 3527 0

Eligibility
Key inclusion criteria
For asthmatic subjects: Inclusion criteria are doctor diagnosis of asthma, and FEV1 ³ 50% predicted.
For COPD subjects: Inclusion criteria are doctor diagnosis of COPD, 15 pack year smoking history, FEV1 ³ 50% predicted.
Minimum age
50 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Asthmatic exclusion criteria: are current smoking, or > 10 pack year history of smoking, respiratory infection or prednisone use in the last 4 weeks.
COPD exclusion criteria are current smoking and respiratory infection in the 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
1/04/2006
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
1/04/2007
Date of last data collection
Anticipated
Actual
1/04/2007
Sample size
Target
45
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1614 0
Charities/Societies/Foundations
Name [1] 1614 0
Asthma Foundation of New South Wales
Country [1] 1614 0
Australia
Primary sponsor type
Other
Name
Woolcock Institute of Medical Research
Address
Country
Australia
Secondary sponsor category [1] 1416 0
None
Name [1] 1416 0
NIL
Address [1] 1416 0
Country [1] 1416 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3062 0
Woolcock Institute of Medical Research, Royal Prince Alfred Hospital
Ethics committee address [1] 3062 0
Level 3 Building 92Royal Prince Alfred Hospital. Camperdown. NSW. 2050
Ethics committee country [1] 3062 0
Australia
Date submitted for ethics approval [1] 3062 0
Approval date [1] 3062 0
Ethics approval number [1] 3062 0
X06-0046
Ethics committee name [2] 3063 0
Department of Respiratory Medicine-Royal North Shore Hospital
Ethics committee address [2] 3063 0
Level 8, Royal North Shore HospitalSt Leonards. NSW. 2065
Ethics committee country [2] 3063 0
Australia
Date submitted for ethics approval [2] 3063 0
Approval date [2] 3063 0
02/02/2006
Ethics approval number [2] 3063 0
0512-232M (SP)

Summary
Brief summary
Airway hyperresponsiveness (AHR) is an important feature of asthma, but its cause is unknown. Recently, we discovered that uneven distribution of air within the lungs is a strong predictor of AHR. We hypothesise that structural changes in the airways cause this uneven distribution and make the airways prone to AHR. Older people with asthma, particularly those with permanently narrowed airways, have more structural changes in their airways, whereas people with chronic obstructive pulmonary disease (COPD) have a different pattern of structural changes from that in asthma. Evidence that there is a consistent relationship between AHR and uneven ventilation in these populations would support our hypothesis
Trial website
Trial related presentations / publications
Unknown
Public notes

Contacts
Principal investigator
Name 27951 0
Address 27951 0
Country 27951 0
Phone 27951 0
Fax 27951 0
Email 27951 0
Contact person for public queries
Name 10533 0
Sarah Newton-John
Address 10533 0
PO Box M77
Missenden Rd
Camperdown NSW 2050
Country 10533 0
Australia
Phone 10533 0
+61 2 95156578
Fax 10533 0
+61 2 95505865
Email 10533 0
[email protected]
Contact person for scientific queries
Name 1461 0
Ms Sue Downie
Address 1461 0
PO Box M77
Missenden Rd
Camperdown NSW 2050
Country 1461 0
Australia
Phone 1461 0
+61 2 95157524
Fax 1461 0
+61 2 95506115
Email 1461 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.