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Instrument Utility for Suspected Asthma (0000-042)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00211575
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Asthma Behavioral: Disease Management Assessment

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected Asthma
Study Start Date : May 2003
Primary Completion Date : December 2004
Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
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

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): NCT00211575


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00211575     History of Changes
Other Study ID Numbers: 0000-042
042
2005_073
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases