Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: fluticasone propionate/salmeterol xinafoate combination (Drug); inhaled corticosteroids (Drug)
Phase: N/A
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
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.
Clinical Details
Official title: Outcomes for Medicare Asthma Patients Taking Fluticasone Propionate/Salmeterol Xinafoate Combination Versus Inhaled Corticosteroids or Other Combination Therapy
Study design: Observational Model: Cohort, Time Perspective: Retrospective
Primary outcome: Mean Number of Post-index Asthma-related Events Measured Using Medical and Pharmacy Claims
Secondary outcome: Mean Asthma-related Costs in the Post-index PeriodMean Number of Albuterol (Short-acting β-Agonists) Canisters Dispensed Per Pharmacy Claim Per Participant
Eligibility
Minimum age: 65 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: July 2009
Last updated: July 28, 2011
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