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WheezoMeter® Correlation Study

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.
 
ClinicalTrials.gov Identifier: NCT01556958
Recruitment Status : Terminated (Device revised)
First Posted : March 19, 2012
Last Update Posted : August 19, 2013
Sponsor:
Information provided by (Responsible Party):
iSonea

Study Description
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Brief Summary:
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 or disease
Asthma Bronchiolitis

Study Design
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Study Type : Observational
Actual Enrollment : 19 participants
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.
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013
Groups and Cohorts
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Group/Cohort
Active Wheezing - age 5-12
Active Wheezing - under age 5
No Wheezing


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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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
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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
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United States, California
Site 1
Folsom, California, United States, 95630
Sponsors and Collaborators
iSonea
More Information
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Responsible Party: iSonea
ClinicalTrials.gov Identifier: NCT01556958    
Other Study ID Numbers: iS-2012-Wz
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: August 19, 2013
Last Verified: August 2013
Additional relevant MeSH terms:
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Bronchiolitis
Bronchitis
Respiratory Tract Infections
Infections
 Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases