Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Overview
- Phase
- Not Applicable
- Intervention
- fluticasone propionate/salmeterol xinafoate combination
- Conditions
- Asthma
- Sponsor
- GlaxoSmithKline
- Enrollment
- 17448
- Primary Endpoint
- Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Medicare-eligible subjects with asthma
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
Intervention: fluticasone propionate/salmeterol xinafoate combination
Medicare-eligible subjects with asthma
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
Intervention: inhaled corticosteroids
Outcomes
Primary Outcomes
Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Time Frame: 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.
Secondary Outcomes
- 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)