Clinical trial NCT01156818: Wheezometer™ Exploratory (WM) Field Study
Official title: Wheezometer™ Exploratory (WM) Field Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Sounds
Wheezing
Keywords: Wheeze measurements
Lead sponsor: KarmelSonix Ltd.
Sponsor class: INDUSTRY
First posted: 2010-07-05
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Asthma patients

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.


Eligibility 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.

Primary outcomes:
measure: Wz% change in response to BD. Symptom score by e-Diary; Spirometer - FEV1.0/FVC/PEF/MEF50 with automated storage and timing
timeFrame: 2 weeks
Secondary outcomes:
measure: Correlate Wz% to FEV1.0: within patient correlation
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Allergy and Asthma Medical Group, Inc.
state: California
Study officials:
affiliation: KarmlSonix
name: Ross Wilson
role: STUDY_DIRECTOR
References: