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Asthma Severity and Therapy Monitoring by Acoustics (ASThMA)

Asthma Severity and Therapy Monitoring by Acoustics (ASThMA) in asthmatics

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12607000400460
Enrollment
30
Registered
2007-08-03
Start date
2007-10-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Primary Hypothesis: That wheeze detection technology and acoustic transmission methods can detect changes in sound transmission that are reflective of changes in airflow obstruction in asthma. Aims: To characterise wheeze detection technology and acoustic transmission methods in patients with asthma in a variety of clinical situations and to correlate these with conventional clinical and spirometric assessment.

Interventions

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

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.

Sponsors

PulmoSonix Pty Ltd
Lead SponsorCommercial sector/Industry

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026