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WheezoMeter® Correlation Study

This study is currently recruiting participants.

Verified March 2012 by iSonea

Sponsor:

Information provided by (Responsible Party):

iSonea

ClinicalTrials.gov Identifier:

NCT01556958

First received: March 15, 2012

Last updated: March 16, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 15, 2012
Last Updated Date	March 16, 2012
Start Date ^ICMJE	March 2012
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01556958 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	WheezoMeter® Correlation Study
Official Title ^ICMJE	Prospective Comparative Study of WheezeRATE™ (Wz%) Readings With Spirometry, Symptoms, and Auscultatory Findings in Children With Wheezing.
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Pediatric Specialty Clinic
Condition ^ICMJE	Asthma Bronchiolitis
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Active Wheezing - age 5-12 Active Wheezing - under age 5 No Wheezing
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	95
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	up to 12 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01556958
Other Study ID Numbers ^ICMJE	iS-2012-Wz
Has Data Monitoring Committee	Not Provided
Responsible Party	iSonea
Study Sponsor ^ICMJE	iSonea
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	iSonea
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP