Instrument Utility for Suspected Asthma (0000-042)(COMPLETED)
January 2, 2015 updated by: Merck Sharp & Dohme LLC
Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected Asthma
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
400
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 6 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
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Utility of ARQ as measured by the percentage of children started on any asthma medication and characteristics of those diagnosed with asthma
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Secondary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (ACTUAL)
December 1, 2004
Study Completion (ACTUAL)
December 1, 2004
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 21, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
January 5, 2015
Last Update Submitted That Met QC Criteria
January 2, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-042
- 042
- 2005_073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.