Instrument Utility for Suspected Asthma
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00211575
First received: September 13, 2005
Last updated: October 27, 2009
Last verified: October 2009
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | October 27, 2009 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Utility of ARQ as measured by the percentage of children started on any asthma medication and characteristics of those diagnosed with asthma | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00211575 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Instrument Utility for Suspected Asthma | ||||
| Official Title ICMJE | Clinical Utility of an Instrument in the Evaluation of Young Children With Suspected 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Asthma | ||||
| Intervention ICMJE | Behavioral: Disease Management Assessment | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 400 | ||||
| Completion Date | December 2004 | ||||
| Primary Completion Date | December 2004 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 6 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00211575 | ||||
| Other Study ID Numbers ICMJE | 2005_073, 042 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc. | ||||
| Study Sponsor ICMJE | Merck | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Merck | ||||
| Verification Date | October 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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