Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy

Study Overview
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Brief Summary
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The objective of this study is to compare healthcare utilization and costs in Medicare-eligible asthma patients (aged >65) who receive fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids in a typical clinical practice using a retrospective observational cohort study design of large managed care database. Outcomes on interest include asthma related severe exacerbations defined as asthma related emergency department visits, hospitalizations or combined emergency department/hospitalization. Other outcomes of interest include use of albuterol, oral corticosteroids and overall asthma related costs. Outcomes of interest will be compared between the two treatment cohorts (fluticasone propionate/salmeterol xinafoate combination or inhaled corticosteroids). Dichotomous outcomes (emergency visits, hospitalizations etc) will be compared using Cox regression hazards analysis assessing time to first event for each asthma related endpoint adjusting for differences in baseline demographics such as age, gender, previous asthma medication use, co morbidities, costs, and plan demographics. Total asthma related costs will also be compared using generalized linear models adjusting for baseline differences.

Official Title
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Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy

Conditions
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Asthma

Intervention / Treatment
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* Drug: fluticasone propionate/salmeterol xinafoate combination
* Drug: inhaled corticosteroids


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 65 years of age prescription for an inhaled corticosteroid Exclusion Criteria: a diagnosis of chronic obstructive pulmonary disease or a prescription for a chronic obstructive pulmonary disease treatment

Ages Eligible for Study
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Minimum Age: 65 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 |
| --- | --- |
| Medicare-eligible subjects with asthma<br>Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan. | Drug: fluticasone propionate/salmeterol xinafoate combination<br>* Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)<br>* Other names: Advair (TM);Drug: inhaled corticosteroids<br>* Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims | Asthma-related events were defined as events with any primary ICD-9 code of 493.xx for hospitalizations, emergency department visits, and combined hospitalization/emergency department visits. The post-index period is defined as 3-12 months after either the first administration of fluticasone propionate and salmetrol or inhaled corticosteroids. Medical and pharmacy claims are recorded healthcare encounters in a large managed care administrative insurance database. | Up to 7 years from July 1, 2001 to June 30, 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Asthma-related Costs in the Post-index Period | Asthma-related costs were calculated as pharmacy costs, medical costs, and total asthma (pharmacy plus medical) costs. Medical costs were made up of asthma-related visits, hospitalizations, emergency department visits, and medical office visits. Pharmacy costs were comprised of all asthma-related medications used during the follow-up period. Medical services were identified by place of service and PharMetrics-specific confinement codes. Prescriptions were counted by 30-day fills, with fills less than 30 days rounded up to indicate one fill. | Up to 7 years from July 1, 2001 to June 30, 2008 | 
| Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant | The number of albuterol canisters dispensed was used as a surrogate marker of asthma symptoms. | Up to 7 years from July 1, 2001 to June 30, 2008 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, treatment, Advair and inhaled corticosteroids, Medicare, Outcomes, costs