Instrument Utility for Suspected Asthma - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00211575

Purpose

This research study was designed to help improve the diagnosis and treatment of asthma in young children. An interventional strategy using a scoring system based on risk factors and symptoms/episodes was tested to determine its ability to identify children likely to benefit from induction of asthma controller therapy at an early age. The score was derived through completion of a survey instrument referred to as the asthma risk questionnaire (ARQ). The utility of the ARQ along with the health care utilization and use of controller therapy for respiratory illnesses within one year were examined.

Condition	Intervention
Asthma	Behavioral: Disease Management Assessment

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected Asthma

Further study details as provided by Merck:

Primary Outcome Measures:

Utility of ARQ as measured by the percentage of children started on any asthma medication and characteristics of those diagnosed with asthma

Secondary Outcome Measures:

Percentage of children with recurrent wheezing, placed on controller therapy, number of steroid courses and need for urgent medical care at 6 and 12 months

Estimated Enrollment:	400
Study Start Date:	May 2003

Eligibility

Ages Eligible for Study:	up to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children less than or equal to 6 years of age who had at least 1 year prior episode of wheezing

Exclusion Criteria:

Children with other systemic or chronic respiratory disease and children who used an asthma controller medication with the 6 weeks prior to enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211575

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2005_073
Study First Received:	September 13, 2005
Last Updated:	October 25, 2005
ClinicalTrials.gov Identifier:	NCT00211575
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009