Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the predictive ability of three asthma risk markers: the ratio of controller medication to total asthma medication, an albuterol only marker, and an oral corticosteroid use marker, as well as to compare the precision of these tools between adult and pediatric patient populations. This retrospective longitudinal analysis will use 2 different databases: a large managed care database and a large fee for service Medicaid database.

Official Title
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Predictive Ability of Therapeutic Risk Factors in Pediatric and Adult Asthma Patients

Conditions
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Asthma

Intervention / Treatment
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* Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with asthma as determined by ICD-9 codes and asthma drug use at least 4 years of age use of at least 1 controller or at least 5 albuterol prescriptions in 12 months Exclusion Criteria: Subjects with COPD or treatment for COPD

Ages Eligible for Study
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Minimum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric participants<br>Pediatric participants (age 4 to 17) with a diagnosis of asthma | Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication<br>* participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.<br>|
| Adult participants<br>Adult participants (age 18 and older) with a diagnosis of asthma | Drug: Asthma treatment with an asthma-related medication and at least one asthma controller medication<br>* participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Ratio of Controller Medication to Total Asthma Medication | The ratio of controller medication (CM) to total asthma medication (AM), which is well established in predicting future asthma events in adults, was calculated as the ratio of the units of CMs used during the defined period divided by the sum of the units of CMs plus the units of inhaled short-acting beta-agonists used during the same period. A CM is defined as any inhaled corticosteroid containing medication, methylxanthines, leukotriene receptor antagonists, or cromolyn sodium. The ratio is calculated using all CM. Asthma controllers are medications used to treat asthma on a regular basis. | January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Short-acting Beta-agonist (SABA) Canisters Used | The number of albuterol canisters dispensed is a marker that is well established in predicting future asthma events in an adult population. | January 1, 2004 to June 30, 2006: 3, 6, and 12 month follow-up periods | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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outcomes, pediatrics, Medicaid, asthma, asthma medication ratio