Observed Outcomes Associated With Fluticasone Propionate/Salmeterol Xinafoate or Inhaled Corticosteroids in Asthma Patients
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      This is an observational retrospective analysis of linked pharmacy and medical claims data
      from IMS Health/Pharmetrics database. which is a comprehensive, de-identified United States
      (US) healthcare claims database that is representative of the non-elderly, insurance-carrying
      population, The total population is 35.4 million. The average length of follow-up is 2.7
      years mean (2.2 years median).

      Subjects will be identified in the database that have at least one ICD-9 diagnostic code
      (493.xx) for asthma and at least 1 asthma treatment within a 12-month period prior to the
      index use of fluticsasone propionate/salmeterol xinafoate or inhaled corticosteroids.
      Subjects will be followed in the database until they have the event of interest
      (asthma-related emergency department visit, hospitalization, or oral corticosteroid use or
      combination of asthma-related emergency department/hospitalization or asthma-related
      emergency department/hospitalization/oral corticosteroids) or until they are lost to follow
      up whichever comes first. Subjects can be censored if they leave the database, have the event
      of interest, or are dispensed another asthma controller other than the medication of
      interest. All outcomes will be assessed in the follow-up period. Time-dependent statistical
      models adjusting for differences in baseline (pre-index) asthma and patient demographics will
      be used to compare asthma events.
    


Intervention name(s): Higher-dose inhaled corticosteroids; Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination
Intervention type(s): Drug; Drug
Intervention description(s): fluticasone propionate 110 or 220 mcg; Low dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg)
Other intervention name(s): Flovent® is a registered trademark of GlaxoSmithKline; Advair ® is a registered trademark of GlaxoSmithKline
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asthma subjects identified from the IMS Health/Pharmetrics database, which is a
        comprehensive, de-identified United States (US) healthcare claims database that is
        representative of the non-elderly, insurance-carrying population, The total population is
        35.4 million. The average length of follow-up is 2.7 years mean (2.2 years median).
        Subjects will be identified using asthma ICD-9 codes (493.xx) and use of asthma
        medications. Subjects will be between the ages of 12 and 65 without comorbid chronic
        obstruction pulmonary disease. To be included in the analysis, subjects will need a
        dispensing history of either fluticasone propionate/salmeterol xinafoate 250 mcg/50 mcg or
        100mcg/50mcg combinations or fluticasone propionate 110 mcg or 220 mcg.
      
Keywords: outcomes; observational; retrospective; database; asthma