Wheezometer™ Exploratory (WM) Field Study
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 8 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | July 2010 |
| End Date: | December 2011 |
| Contact: | Ross Wilson |
| Email: | rossw@karmelsoinx.com |
| Phone: | 909-989-0033 |
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.
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.
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.
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