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NCT01927172 Clinical Trial

AirSonea Wheeze Detection Study

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01927172
Other study ID # iS-2013-Wz
Secondary ID
Status Not yet recruiting
Phase N/A
First received August 2, 2013
Last updated August 19, 2013
Start date September 2013

Study information
Verified date August 2013
Source iSonea
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 85
Est. completion date
Est. primary completion date August 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- Any medical finding by the physician that would exclude the patient from participating.

- < than 18 years of age

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• AirSonea

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
iSonea

Outcome
Type Measure Description Time frame Safety issue
Primary Device Efficacy Device wheeze detection as compared to physician wheeze detection via auscultation. 1 day No
Secondary Wheeze Rate break points Wheeze Rate break points for the user of rescue inhalers Up to 1 week No
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