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

GlaxoSmithKline (GSK) logo

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Asthma

Treatments

Drug: fluticasone propionate/salmeterol xinafoate combination
Drug: inhaled corticosteroids

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

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.

Enrollment

17,448 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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

Trial design

17,448 participants in 1 patient group

Medicare-eligible subjects with asthma
Description:
Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.
Treatment:
Drug: inhaled corticosteroids
Drug: fluticasone propionate/salmeterol xinafoate combination

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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