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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00211575
Enrollment
400
Registered
2005-09-21
Start date
2003-05-31
Completion date
2004-12-31
Last updated
2015-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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.

Interventions

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Years
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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026