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WheezoMeter® Correlation Study

This study has been terminated.
(Device revised)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556958
First Posted: March 19, 2012
Last Update Posted: August 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
iSonea
  Purpose
The primary goal of the study is to more firmly establish correlations between WheezeRate(Wz%) and other parameters used to assess wheezing and asthma including spirometry, provider's auscultation, and symptoms at the time of Wz% measurement.

Condition
Asthma Bronchiolitis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.

Further study details as provided by iSonea:

Enrollment: 19
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Active Wheezing - age 5-12
Active Wheezing - under age 5
No Wheezing

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Pediatric Specialty Clinic
Criteria

Inclusion Criteria:

  • Patients <= 12 years of age who have wheezing at the time of study as confirmed by the physicians' auscultation.

Control:

  • Patients <= 12 years of age without history of asthma or other pulmonary conditions, and who are without wheezing on physical exam.

Exclusion Criteria:

  • Medical problems that would contraindicate Wz% measurement.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556958


Locations
United States, California
Site 1
Folsom, California, United States, 95630
Sponsors and Collaborators
iSonea
  More Information

Responsible Party: iSonea
ClinicalTrials.gov Identifier: NCT01556958     History of Changes
Other Study ID Numbers: iS-2012-Wz
First Submitted: March 15, 2012
First Posted: March 19, 2012
Last Update Posted: August 19, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections