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
ACTRN12605000334606
Ethics application status
Approved
Date submitted
7/09/2005
Date registered
7/09/2005
Date last updated
7/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does obesity increase the risk of developing asthma?
Scientific title
Obesity, Inflammation and Asthma - Is there an inter-relationship?
Universal Trial Number (UTN)
Trial acronym
MAISI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 426 0
Obesity 427 0
Condition category
Condition code
Respiratory 496 496 0 0
Asthma
Diet and Nutrition 497 497 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Non-interventional observational study
Intervention code [1] 390 0
None
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 564 0
Plasma CRP and cytokines
Timepoint [1] 564 0
Primary outcome [2] 565 0
Induced sputum supernatant levels of cytokines and oxidative stress
Timepoint [2] 565 0
Primary outcome [3] 566 0
Induced sputum cell counts
Timepoint [3] 566 0
Primary outcome [4] 567 0
Body fat composition
Timepoint [4] 567 0
Primary outcome [5] 568 0
Pulmonary function
Timepoint [5] 568 0
Secondary outcome [1] 1205 0
No secondary outcomes.
Timepoint [1] 1205 0

Eligibility
Key inclusion criteria
Obese women BMI>32, Non-obese women BMI<25, asthma as defined by ATS.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Men, Smokers, Subjects on oral steroids and those on inhaled steroids will have them withdrawn, pregnancy, breast feeding, hormonal replacement or contracteption, non-asthmatics with a exhaled nitric oxide >30 or atopy to skin prick testing.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 178 0
New Zealand
State/province [1] 178 0

Funding & Sponsors
Funding source category [1] 559 0
University
Name [1] 559 0
Otago univesity
Country [1] 559 0
New Zealand
Funding source category [2] 560 0
Charities/Societies/Foundations
Name [2] 560 0
Otago Medical Research Foundation
Country [2] 560 0
New Zealand
Primary sponsor type
University
Name
Univestiry of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 453 0
None
Name [1] 453 0
None
Address [1] 453 0
Country [1] 453 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35867 0
Address 35867 0
Country 35867 0
Phone 35867 0
Fax 35867 0
Email 35867 0
Contact person for public queries
Name 9579 0
Dr Tim Sutherland
Address 9579 0
Respiratory Research Unit
Department of Medical and Surgical Sciences
Dunedin Hospital
PO Box 913
Dunedin
Country 9579 0
New Zealand
Phone 9579 0
+64 3 4740999 (Ext. 8785)
Fax 9579 0
Email 9579 0
[email protected]
Contact person for scientific queries
Name 507 0
Professor Robin Taylor
Address 507 0
Respiratory Research Unit
Department of Medical and Surgical Sciences
Dunedin Hospital
PO Box 913
Dunedin
Country 507 0
New Zealand
Phone 507 0
+64 3 4740999 (Ext. 8785)
Fax 507 0
Email 507 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.