Wheezometer™ Exploratory (WM) Field Study

NCT01156818 | Unknown

• 1 other identifier: KSI-MUL-GEN-WMF-01
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Sounds; Wheezing

Keywords

Wheeze measurements

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Correlate Wz% to FEV1.0: within patient correlation

  2 weeks

Study Arms (2)

Children

Age 8-21 years

Adult

Age 21-80 years

Eligibility Criteria

• Age: 8 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Asthma patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KarmelSonix Ltd.: lead

Study Sites (1)

California Allergy and Asthma Medical Group, Inc.

Los Angeles, California, 90025, United States

RECRUITING

MeSH Terms

Conditions

Respiratory Sounds

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ross Wilson

  KarmlSonix

  STUDY DIRECTOR

Central Study Contacts

Ross Wilson

CONTACT

909-989-0033; rossw@karmelsoinx.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 2, 2010
• First Posted: July 5, 2010
• Study Start: July 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 9, 2011

Record last verified: 2010-07

Locations

US (1)