Asthma Comparative Effectiveness Study

Study Overview
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Brief Summary
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The objective of this study is to compare the real-world effectiveness of BFC and FSC in asthma patients new to ICS/LABA combination therapy in a population of U.S. health plan enrollees.

Detailed Description
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A U.S. retrospective database analysis evaluating the comparative effectiveness of budesonide/formoterol and fluticasone propionate/salmeterol among asthma patients

Official Title
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A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol Combination (BFC) and Fluticasone Propionate/Salmeterol Combination (FSC) Among Asthma Patients

Conditions
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Asthma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Continuous health plan enrollment for 12 months before and after index Rx At least two prescription fills for BFC or FSC within 12 months Asthma claims diagnosis, and 12 to 64 years of age at the time of first prescription Exclusion Criteria: Evidence of COPD Claims diagnosis of any of inflammatory diseases or cancer Presence of Rx for more than one type of ICS/LABA combination on index date Chronic steroid use or Xolair use prior to ICS/LABA index treatment

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 64 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 |
| --- | --- |
| Symbicort<br>BFC patients new to ICS/LABA combination therapy | |
| Advair<br>FSC patients new to ICS/LABA combination therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of asthma exacerbations | The rate is defined as the total number of asthma exacerbations for all patients in the cohort divided by the total number of person years. An asthma exacerbation is defined as any of three conditions: Asthma related inpatient hospitalization or Asthma related emergency department visit or Oral corticosteroid use. | 12 months | 
| Asthma Related Inpatient Hospitalizations |  | 12 months | 
| Asthma Related Emergency Department visits |  | 12 months | 
| Use of Oral Corticosteroids (OCS) | A pharmacy claim for any of the OCS medications | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma controller medication use (SABA, ICS, LABA, LTRA, XOLAIR, THEOPHYLLINE) | Asthma controller use (0 vs. 1 and total number of fills for each). | 12 months | 
| Asthma Related Healthcare Utilization | Asthma Related Healthcare Utilization: Outpatient/office visits, Inpatient length of stay, ICU admission and length of stay. | 12 months | 
| Asthma Related Healthcare costs | Asthma Related Healthcare costs (plan paid, patient paid and plan + patient paid)costs of all Asthma related medication and Asthma related outpatient/office, ED and Inpatient visits. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Comparative Effectiveness, Symbicort