Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000624987
Ethics application status
Approved
Date submitted
7/12/2009
Date registered
20/06/2011
Date last updated
20/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Use of an Electronic Nose to Distinguish Between Bacterial and Non-Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease.
Scientific title
An Observational Study on The Use of an Electronic Nose to Distinguish Between Bacterial and Non-Bacterial Exacerbations of Chronic Obstructive Pulmonary Disease.
Secondary ID [1] 262411 0
None
Universal Trial Number (UTN)
Trial acronym
NOSE-COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic obstructive pulmonary disease (COPD) 252353 0
Condition category
Condition code
Respiratory 256542 256542 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
No intervention. Exhaled breath sampling during and after Acute Exacerbation of COPD (AECOPD). Collection of exhaled breath via facemask into a reservoir, and subsequent analysis of volatile organic compund profiles by electronic nose. This is a novel 32 sensor device which records a VOC "pattern" which can be used for discrimination of samples. Also characterisation of patients into infected / non-infected groups by use of sputum and blood cultures, nasopharyngeal swab for respiratory virus screen by PCR, serology etc. 1-2 years. Also analysis of exhaeled breath by PTR-MS. Exhaled breath samples are taken at exacerbation and again at recovery (approx 6 weeks later) in the patients group, and only once in the control group.
Intervention code [1] 255663 0
Not applicable
Comparator / control treatment
Otherwise well patients with stable COPD recruited from pulmonary rehabilitation courses. No interventions made, sampling only.
Control group
Active

Outcomes
Primary outcome [1] 253424 0
Difference in electronic nose output for active AECOPD and stable controls (internal and external) by statistical analysis
Timepoint [1] 253424 0
4 weeks after electronic nose analysis
Secondary outcome [1] 262541 0
Difference in electronic nose output between bacterial and viral associated exacerbations, by standard statistical analysis
Timepoint [1] 262541 0
4 weeks as above.

Eligibility
Key inclusion criteria
Diagnosed COPD
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Forced Expiratory Volume in 1 second (FEV1) / Forced Vital Capacity (FVC) percentage (FEV1/FVC) greater than 70%
(FEV1) less than 40% predicted
Other significant pulmonary disease

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 2355 0
New Zealand
State/province [1] 2355 0
Otago

Funding & Sponsors
Funding source category [1] 256142 0
Hospital
Name [1] 256142 0
Healthcare Otago Charitable Trust
Country [1] 256142 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Dept Medical and Surgical Sciences
Dunedin School of Medicine
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 251483 0
Other Collaborative groups
Name [1] 251483 0
Mornington Health Centre Limited
Address [1] 251483 0
Mornington Health Centre. Eglington Road, Mornington, Dunedin 9010
Country [1] 251483 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258235 0
Lower South Ethics Committee
Ethics committee address [1] 258235 0
Health & Disability Services Policy Group
Population Health Directorate
Ministry of Health
Dunedin 9010
Ethics committee country [1] 258235 0
New Zealand
Date submitted for ethics approval [1] 258235 0
27/11/2009
Approval date [1] 258235 0
01/12/2010
Ethics approval number [1] 258235 0
LRS/09/11/055

Summary
Brief summary
The electronic Nose detects and analyses volatile organic compounds in a gas sample. It has previously been used in the food industry and to detect explosives. By sampling exhaled air in a single breath from a patient, the technology can be used to provide a profile which may define underlying pathology in the airways and lung. In this study we will obtain recordings using the Nose from otherwise well patients with chronic obstructive pulmonary disease (COPD) undergoing pulmonary rehabilitation (n=50) and patients experiencing an acute exacerbation of COPD (n=50). We will compare the Nose signal between these groups, and assess them for the presence or absence of bacterial infection, to see whether there is a nose signal which is characteristic for bacterial infection (which might indicate the need for antibiotic therapy). The aim is to develop bedside technology which is easy to use and provides clinicians with practical information as to whether or not an acute exacerbation is or is not caused by bacterial rather than viral infection. Patients will receive best standard care and the results of the Nose sampling will not alter their standard treatment in any way.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30591 0
Address 30591 0
Country 30591 0
Phone 30591 0
Fax 30591 0
Email 30591 0
Contact person for public queries
Name 13838 0
Dr Ben Brockway
Address 13838 0
Dunedin School of Medicine,
University of Otago,
P.O. Box 913,
Dunedin, 9016
New Zealand
Country 13838 0
New Zealand
Phone 13838 0
+64 3 474 0999 x8785
Fax 13838 0
Email 13838 0
[email protected]
Contact person for scientific queries
Name 4766 0
Professor Robin Taylor
Address 4766 0
Dunedin School of Medicine,
University of Otago,
P.O. Box 913,
Dunedin, 9016
New Zealand
Country 4766 0
New Zealand
Phone 4766 0
+64 3 474 0999 x8785
Fax 4766 0
Email 4766 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
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