Real life effectiveness and cost impact evaluation of fixed dose combination fluticasone propionate/formoterol (Flutiform®) compared to fluticasone propionate/salmeterol (Seretide®) (eFFectiveness)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE PROPIONATE

  FORMOTEROL

  SALMETEROL
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Adolescent and adult asthmatic patients who have received ≥2 fluticasone propionate/formoterol prescriptions during the outcome period for treatment groups exclusive of prescription at index date, or : ≥2 fluticasone propionate/salmeterol prescriptions for control groups exclusive of prescription at index date.
• Age groups:
  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  43504

Study design details

• Main study objective:
  To examine non-inferiority of effectiveness (in terms of ‘no exacerbations’ ATS/ERS Task Force definition) of fluticasone propionate / formoterol (Flutiform®, FP/FOR) relative to fluticasone propionate / salmeterol (Seretide®, FP/SAL) in matched patients from two cohorts of patients with asthma
• Outcomes:
  To evaluate whether asthma patients treated with FP/FOR are associated with a non-inferior proportion with no exacerbations when compared to asthma patients treated with FP/SAL, To evaluate comparative effectiveness and cost impact outcomes of fluticasone propionate / formoterol (Flutiform®, FP/FOR) relative to fluticasone propionate / salmeterol (Seretide®, FP/SAL) in matched patients from two cohorts of patients with asthma
• Data analysis plan:
  Patients will be combined from two cohorts - those who initiated on a fixed dose combination ICS/LABA and those who change to FP/FOR or continue on FP/SAL. Patients will be matched on one year of baseline characteristics including age, gender, spirometry, exacerbations, rhinitis, smoking status and predicted peak flow. After matching, adjusted analysis was provided for the primary outcome (proportion of patients with no exacerbations). A difference of less than 3.5% of the lower 95% confidence interval between the comparator (FP/FLU) and the control (FP/SAL) was considered to be non-inferior. Additional secondary outcomes are compared as appropriate using odds ratios, rate ratios and conditional logistic regression. Cost impact was compared through assessment of lower respiratory related medication, lower respiratory resource use and the combined medication and resource use after matching.

Documents

Study results

R03212c_Statistical_Report_v1