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

Asthma Clinical Trial

Official title:

Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211575
• Other study ID #: 0000-042
• Secondary ID: 0422005_073
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: January 2, 2015
• Start date: May 2003
• Est. completion date: December 2004

Study information

• Verified date: January 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Disease Management Assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utility of ARQ as measured by the percentage of children started on any asthma medication and characteristics of those diagnosed with asthma
Secondary	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