Status:
UNKNOWN
Wheezometer™ Exploratory (WM) Field Study
Lead Sponsor:
KarmelSonix Ltd.
Conditions:
Respiratory Sounds
Wheezing
Eligibility:
All Genders
8-80 years
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. W...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01156818
Start Date
July 1 2010
End Date
December 1 2011
Last Update
June 9 2011
Active Locations (1)
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1
California Allergy and Asthma Medical Group, Inc.
Los Angeles, California, United States, 90025