Clinical Trial: Wheezometer™ Exploratory (WM) Field Study

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

Official Title: Wheezometer™ Exploratory (WM) Field Study

Brief Summary:

Karmel Sonix Ltd has developed the Personal WheezoMeter a hand-held pulmonary sounds analyzer that utilizes contact sensors to acquire, amplify, filter, record and quantify the presence of wheezing. When used to monitor conditions such as asthma, this device should be used under the direction of a physician or licensed healthcare professional. The device is intended for use with pediatric and adult patients in both home and clinical settings.

The purpose of the study is to determine whether Wz% and change in Wz% correlate with symptoms and change in symptoms at least as well as FEV1 and change in FEV1.0. Additional information to be obtained from the study will be to determine whether there is a symptom threshold at which a patient seeks rescue medications and if so, to determine the value of Wz% and FEV1.0 at this point (Wz%, FEV1.0 thresholds). The study will also provide information on the within patient and whole group correlations between Wz% and FEV.

Detailed Summary:
Sponsor: KarmelSonix Ltd.

Current Primary Outcome: Wz% change in response to BD. Symptom score by e-Diary; Spirometer - FEV1.0/FVC/PEF/MEF50 with automated storage and timing [ Time Frame: 2 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Correlate Wz% to FEV1.0: within patient correlation [ Time Frame: 2 weeks ]

Original Secondary Outcome: Same as current

Information By: KarmelSonix Ltd.

Dates:
Date Received: July 2, 2010
Date Started: July 2010
Date Completion: December 2011
Last Updated: June 8, 2011
Last Verified: July 2010