Wheezometer™ Exploratory (WM) Field Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by KarmelSonix Ltd..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
KarmelSonix Ltd.
ClinicalTrials.gov Identifier:
NCT01156818
First received: July 2, 2010
Last updated: June 8, 2011
Last verified: July 2010
  Purpose

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.


Condition
Respiratory Sounds
Wheezing

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Wheezometer™ Exploratory (WM) Field Study

Further study details as provided by KarmelSonix Ltd.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlate Wz% to FEV1.0: within patient correlation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Children
Age 8-21 years
Adult
Age 21-80 years

  Eligibility

Ages Eligible for Study:   8 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asthma patients

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01156818

Contacts
Contact: Ross Wilson 909-989-0033 rossw@karmelsoinx.com

Locations
United States, California
California Allergy and Asthma Medical Group, Inc. Recruiting
Los Angeles, California, United States, 90025
Contact: Ross Wilson    909-989-0033    rossw@karmelsoinx.com   
Principal Investigator: Sheldon Spector, Prof.         
Sponsors and Collaborators
KarmelSonix Ltd.
Investigators
Study Director: Ross Wilson KarmlSonix
  More Information

No publications provided

Responsible Party: Ross Wilson, KarmelSonix
ClinicalTrials.gov Identifier: NCT01156818     History of Changes
Other Study ID Numbers: KSI-MUL-GEN-WMF-01
Study First Received: July 2, 2010
Last Updated: June 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by KarmelSonix Ltd.:
Wheeze measurements

Additional relevant MeSH terms:
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014