Wheezometer™ Exploratory (WM) Field Study

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.

Study Overview

• Status: Unknown
• Conditions: Respiratory Sounds; Wheezing

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Ross Wilson; Phone Number: 909-989-0033; Email: rossw@karmelsoinx.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90025
      • Recruiting
      • California Allergy and Asthma Medical Group, Inc.
      • Contact: Ross Wilson; Phone Number: 909-989-0033; Email: rossw@karmelsoinx.com
      • Principal Investigator: Sheldon Spector, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Asthma patients

Description

Inclusion Criteria:

• Physician diagnosed asthma.
• Poorly controlled asthma as per GINA Guidelines with frequent (i.e. >5/week) use of reliever medications.
• Adequate comprehension level and demonstrated ability to perform unsupervised spirometry, wheezometry and use the symptom diary.
• Age range 8-80. Patients over 40 will only be included if they are lifetime non-smokers, who have demonstrated reversibility of airway obstruction (at least 12% improvement in FEV1.0 after bronchodilator).
• All patients included in the study will be routinely receiving either a short acting bronchodilator or a long acting bronchodilator twice daily as part of their regular medication. Additional doses of bronchodilator will be taken on an as needed basis. No change in regular medication will be made for the purposes of the study.
• Subject or subject's parents/guardians is/are able to comprehend and give informed consent for participation in the study.

Consent of treating physician.

Exclusion Criteria:

• Inability to perform spirometry and/or Wheezometry. Skin Disorder (burn, infection, or allergy) over upper chest (Child) or neck (Adult).
• Patients with other diseases, which in the opinion of the treating physician would interfere with the management of asthma and performance of the study according to the protocol.
• Hospitalization at recruitment, [patients who get admitted while participating will continue to participate].

P- hysician objection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Children; Age 8-21 years
Adult; Age 21-80 years

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlate Wz% to FEV1.0: within patient correlation	2 weeks

Collaborators and Investigators

• Sponsor: KarmelSonix Ltd.
• Investigators: Study Director: Ross Wilson, KarmlSonix

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: July 2, 2010
• First Submitted That Met QC Criteria: July 2, 2010
• First Posted (Estimate): July 5, 2010

Study Record Updates

• Last Update Posted (Estimate): June 9, 2011
• Last Update Submitted That Met QC Criteria: June 8, 2011
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Wheeze measurements
• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds
• Other Study ID Numbers: KSI-MUL-GEN-WMF-01