Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: September 13, 2005
Last updated: January 2, 2015
Last verified: January 2015
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
Behavioral: Disease Management Assessment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected Asthma

Further study details as provided by Merck Sharp & Dohme Corp.:

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
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00211575

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

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00211575     History of Changes
Other Study ID Numbers: 0000-042  042  2005_073 
Study First Received: September 13, 2005
Last Updated: January 2, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases processed this record on October 25, 2016