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

July 2, 2010
June 8, 2011
July 2010
October 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01156818 on ClinicalTrials.gov Archive Site
Correlate Wz% to FEV1.0: within patient correlation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Wheezometer™ Exploratory (WM) Field Study
Wheezometer™ Exploratory (WM) Field Study

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Asthma patients

  • Respiratory Sounds
  • Wheezing
Not Provided
  • Children
    Age 8-21 years
  • Adult
    Age 21-80 years
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2011
October 2011   (final data collection date for primary outcome measure)

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.

Both
8 Years to 80 Years
No
Contact: Ross Wilson 909-989-0033 rossw@karmelsoinx.com
United States
 
NCT01156818
KSI-MUL-GEN-WMF-01
No
Ross Wilson, KarmelSonix
KarmelSonix Ltd.
Not Provided
Study Director: Ross Wilson KarmlSonix
KarmelSonix Ltd.
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP