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

NCT ID: NCT01347060

Last Updated: 2017-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 17448 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-04-30

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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Medicare-eligible subjects with asthma

Asthma subjects at least 65 years of age enrolled in a large Medicare managed care health plan.

fluticasone propionate/salmeterol xinafoate combination

Intervention Type: DRUG

Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)

inhaled corticosteroids

Intervention Type: DRUG

Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide

Interventions

fluticasone propionate/salmeterol xinafoate combination

Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)

Intervention Type: DRUG

inhaled corticosteroids

Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide

Intervention Type: DRUG

Other Intervention Names

Advair (TM)

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Other Identifiers

112605

Identifier Type: -

Identifier Source: org_study_id