COPDNCT01927172
AirSonea Wheeze Detection Study
A study testing AirSonea in people with COPD and Asthma, run by iSonea.
Trial summary
The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- AirSonea
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms
- Part II: Volunteer participants without asthma
- Part III: Participants with asthma
- For all parts of study
- Age: 18 years or older
- Participant has signed an Informed Consent after having the Study explained to them.
Who cannot join
- Any medical finding by the physician that would exclude the patient from participating.
- < than 18 years of age
About this study
Official title: AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.
The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.
- Being tested
- AirSonea
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AirSoneaDevice
Also called No intervention, AirSonea is an adjuct to physician/clinician auscultation.
| Study group | Role | What they receive |
|---|---|---|
| AirSonea | Other | Use of AirSonea to detect wheeze sounds. Receives: Device: AirSonea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device Efficacy
Device wheeze detection as compared to physician wheeze detection via auscultation.
Measured: 1 day
Secondary outcomes (1)
Wheeze Rate break points
Wheeze Rate break points for the user of rescue inhalers
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iSonea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01927172
- Sponsor's protocol ID
- iS-2013-Wz
- Status last verified
- Aug 2013
- First submitted
- 2 Aug 2013
- Last updated
- 22 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AirSonea Wheeze Detection Study - Multipart Clinical Performance Assessment to Determine Agreement on Wheeze Detection Between AirSonea™ Versus Physician Auscultation and an Expert Panel.
- ClinicalTrials.gov ID
- NCT01927172
- Acronym / sponsor ID
- iS-2013-Wz
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- iSoneaIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (estimated)
- First posted
- 22 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if the AirSonea device provides an objective assessment of breath sounds for the presence of wheeze in both medical and home environments.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AirSonea | Other | Device: AirSoneaUse of AirSonea to detect wheeze sounds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Part I: Participants presenting to an Acute Care Setting with an exacerbation of asthma or chronic obstructive pulmonary disease symptoms
- Part II: Volunteer participants without asthma
- Part III: Participants with asthma
- For all parts of study
Key exclusion criteria (2 listed)
- Any medical finding by the physician that would exclude the patient from participating.
- < than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AirSoneaAlso: No intervention, AirSonea is an adjuct to physician/clinician auscultation. | Device | AirSonea |
Primary outcome
Device Efficacy
Time frame: 1 day
Device wheeze detection as compared to physician wheeze detection via auscultation.
1 secondary outcome
Wheeze Rate break points
Time frame: Up to 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing AirSonea in people with COPD and Asthma, run by iSonea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device Efficacy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2013.