Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17,448
- 主要终点
- Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with asthma as determined by ICD-9 codes and asthma drug use
- •at least 65 years of age
- •prescription for an inhaled corticosteroid
排除标准
- •a diagnosis of chronic obstructive pulmonary disease or
- •a prescription for a chronic obstructive pulmonary disease treatment
研究组 & 干预措施
Medicare-eligible subjects with asthma
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
干预措施: fluticasone propionate/salmeterol xinafoate combination (Drug)
Medicare-eligible subjects with asthma
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
干预措施: inhaled corticosteroids (Drug)
结局指标
主要结局
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
时间窗: Up to 7 years from July 1, 2001 to June 30, 2008
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.
次要结局
- Mean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant(Up to 7 years from July 1, 2001 to June 30, 2008)
- Mean Asthma-related Costs in the Post-index Period(Up to 7 years from July 1, 2001 to June 30, 2008)