Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000400460
Ethics application status
Approved
Date submitted
30/07/2007
Date registered
3/08/2007
Date last updated
5/01/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
Asthma Severity and Therapy Monitoring by Acoustics (ASThMA)
Scientific title
Asthma Severity and Therapy Monitoring by Acoustics (ASThMA) in asthmatics
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma 2198 0
Condition category
Condition code
Respiratory 2293 2293 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This first in human device study will enrol patient from 3 different groups. Group 1 will include patients previously diagnosed with asthma using Ventolin to relieve chest tightness or shortness of breath. Group 2 will include patients referred to have a Bronchial Provocation Challenge. Group 3 will include acute asthmatics who have been admitted to the Alfred Hospital for treatment of an asthma exacerbation. Once recruited certain breathing manoeuvres will be requested of the patient while sound is introduced into their upper airways using a nasal cannula or a mouth piece. In addition to a respiratory belt to monitor respiration, a series of microphones will be placed on each patient's back and chest which will record sounds that reach their chest wall. The sound reaching the microphones will have passed through the chest wall and a part of your lung. We predict that the attenuation of sound through airways will be higher i.e. less sound will be transmitted to the microphone, when experiencing asthma symptoms. We also expect wheezes to be detected.
Intervention code [1] 1913 0
Diagnosis / Prognosis
Comparator / control treatment
This is a first in human pilot study and there is no comparator or control being used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3183 0
A correlation between airway narrowing, sound attenuation and wheeze detection.
Timepoint [1] 3183 0
At time of presentation to the hospital (single day trial with no extended follow-up).
Secondary outcome [1] 5309 0
Development of a Asthma Severity Index
Timepoint [1] 5309 0
At time of presentation to the hospital (single day trial with no extended follow-up).

Eligibility
Key inclusion criteria
Three groups of patients will be invited to participate and we aim to include between six and ten subjects in each group:1. Those with asthma, who are clinically stable with known bronchodilator reversibility on the basis of previous spirometric testing and who use inhaled Salbutamol as required.2. Those undergoing bronchial provocation testing as part of their current clinical care.Inpatients of the Alfred Hospital with an admission diagnosis of an exacerbation of asthma.3. All patients must be able to give informed consent.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Skin problems that preclude placement of the sensors with an adhesive 2. Life-threatening condition with the patient's condition being considered "unstable" or "critical" by the attending physician.3. Patient who cannot read and understand the informed consent.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2456 0
Commercial sector/Industry
Name [1] 2456 0
PulmoSonix Pty Ltd
Country [1] 2456 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PulmoSonix Pty Ltd
Address
336A Glenhuntly Road Elsternwick VIC 3185
Country
Australia
Secondary sponsor category [1] 2228 0
None
Name [1] 2228 0
N/A
Address [1] 2228 0
Country [1] 2228 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6362 0
Alfred Hosptial
Ethics committee address [1] 6362 0
Ethics committee country [1] 6362 0
Australia
Date submitted for ethics approval [1] 6362 0
13/12/2007
Approval date [1] 6362 0
13/12/2007
Ethics approval number [1] 6362 0
180/07

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

Contacts
Principal investigator
Name 27727 0
Address 27727 0
Country 27727 0
Phone 27727 0
Fax 27727 0
Email 27727 0
Contact person for public queries
Name 11102 0
Shaun Bowden
Address 11102 0
336A Glenhuntly Road Elsternwick VIC 3185
Country 11102 0
Australia
Phone 11102 0
+61 3 95324283
Fax 11102 0
Email 11102 0
info@pulmosonix.com.au
Contact person for scientific queries
Name 2030 0
Peter Camilleri
Address 2030 0
336A Glenhuntly Road Elsternwick VIC 3185
Country 2030 0
Australia
Phone 2030 0
+61 3 95324283
Fax 2030 0
Email 2030 0
pcamilleri@pulmosonix.com.au

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.