Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000325101p
Ethics application status
Not yet submitted
Date submitted
22/02/2019
Date registered
4/03/2019
Date last updated
4/03/2019
Date data sharing statement initially provided
4/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Observation of breath measurement in Asthmatics
Scientific title
Observation of changes of bio-markers in the breath of Asthmatics
Secondary ID [1] 297488 0
Nil Known
Universal Trial Number (UTN)
U1111-1229-0552
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 311680 0
Condition category
Condition code
Respiratory 310308 310308 0 0
Asthma

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of fractional exhaled nitric oxide (FeNO) using a breath analyser, exhaled breath temperature (EBT) using a breath analyser and lung sounds using an digital stethoscope in participants who have Asthma with atopy. Measurements may be administered by a general practitioner or by a participants who have been trained.

Measurements will be taken during a session lasting up to 10 minutes, 3 times a week for 4 weeks. Measurements will be recorded during each session at the start of 4 week then analysed at the end 4 weeks.
Intervention code [1] 313734 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319192 0
Change in Nitric oxide levels measured using nitric oxide monitor
Timepoint [1] 319192 0
At each visit, 3 times per week for 4 weeks
Primary outcome [2] 319194 0
Change in lung sounds recorded using digital stethoscope
Timepoint [2] 319194 0
At each visit, 3 times per week for 4 weeks
Primary outcome [3] 319195 0
Complete asthma control questionnaire, with time frame modified from 4 weeks to 1 week
Timepoint [3] 319195 0
At beginning of study then at the last visit of each week for 4 weeks
Secondary outcome [1] 367376 0
Change in exhaled breath temperature measured using breath temperature monitor
Timepoint [1] 367376 0
At each visit, 3 times per week for 4 weeks

Eligibility
Key inclusion criteria
Participants who are able to comprehend written and spoken English.

Participants have asthma, preferably with allergic triggers (atopy).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are/maybe pregnant or lactating.
Participants with a pre-existing lung disease/ condition (excluding asthma), for example: COPD; lung cancer; fibrosis of the lungs; recent (<2 years) case of pneumonia or lung infection; lung injury.
Patients with cough or respiratory/ear infection at time of testing.Participant who is not able to blow with correct technique for fractional exhaled nitric oxide or exhaled breath temperature tests.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Data will be imported into Mintab and/or Excel to asses for correlations including:
- Comparison of three (3) daily FeNO readings for test to test variation, rejecting outliers.
- Comparison of FeNO readings with time, EBT, lung sounds, PM2.5, PM10, carbon monoxide,
sulphur dioxide, asthma medication and its usage, asthma symptoms, and total score from
each completed Asthma Control Questionnaire.
Statistical analysis will have performed using 1 sample t test.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
25/03/2019
Actual
Date of last participant enrolment
Anticipated
29/03/2019
Actual
Date of last data collection
Anticipated
10/05/2019
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 302052 0
Commercial sector/Industry
Name [1] 302052 0
ResMed Limited
Country [1] 302052 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
ResMed Limited
Address
1 Elizabeth MacArthur Drive
Bella Vista, NSW, 2153
Country
Australia
Secondary sponsor category [1] 301870 0
None
Name [1] 301870 0
Address [1] 301870 0
Country [1] 301870 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 302734 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 302734 0
Ethics committee country [1] 302734 0
Australia
Date submitted for ethics approval [1] 302734 0
06/03/2019
Approval date [1] 302734 0
Ethics approval number [1] 302734 0

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

Contacts
Principal investigator
Name 91206 0
Dr Martin A. Devitt
Address 91206 0
Lifecycle Medical
PO Box 500 Newport NSW 2106
Country 91206 0
Australia
Phone 91206 0
+61 403 226 310
Fax 91206 0
Email 91206 0
martin@lifecyclemedical.com.au
Contact person for public queries
Name 91207 0
Martin A. Devitt
Address 91207 0
Lifecycle Medical
PO Box 500 Newport NSW 2106
Country 91207 0
Australia
Phone 91207 0
+61 403 226 310
Fax 91207 0
Email 91207 0
martin@lifecyclemedical.com.au
Contact person for scientific queries
Name 91208 0
Martin A. Devitt
Address 91208 0
Lifecycle Medical
PO Box 500 Newport NSW 2106
Country 91208 0
Australia
Phone 91208 0
+61 403 226 310
Fax 91208 0
Email 91208 0
martin@lifecyclemedical.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.