Real-life effectiveness (and cost impact) evaluation of fixed-dose combination fluticasone propionate/formoterol (Flutiform®) for the management of asthma in a routine UK primary care population – Phase 2 (Real-life effectiveness of Flutiform - Phase 2)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Historical

Study drug and medical condition

• Name of medicine, other:
  Seretide, Flutiform
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients aged 12-80 years who had evidence of active asthma, defined as a diagnostic code and/or ≥2 prescriptions for asthma therapy during the baseline year
• 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:
  Renal impaired

  Hepatic impaired

  Immunocompromised

  Pregnant women

  Other
• Special population of interest, other:
  Asthma patients
• Estimated number of subjects:
  154

Study design details

• Main study objective:
  To evaluate the comparative effectiveness of changing real-life asthma patients from fluticasone propionate / salmeterol (Seretide®, FP/SAL) to fluticasone propionate / formoterol (Flutiform®, FP/FOR).
• Outcomes:
  Co-primary outcomes1. Severe exacerbation rate (ATS definition)Defined as any of the following (outcome year):• Asthma-related hospital or emergency room attendance • Acute oral steroid prescriptions for asthma2. Composite proxy asthma control Defined as absence of the following (outcome year):• Severe exacerbations• Antibiotics prescriptions for LRTIs at a respiratory consultation, Secondary outcomes:1. ICS use – mean daily ICS dose2. Short-acting beta2agonist (SABA) use – mean daily SABA doseCost impact outcomes (optional)1. Asthma drug costs ± FDC ICS/LABA drug costs2. Cost of asthma resource utilisation3. Cost of asthma-related resource utilisation
• Data analysis plan:
  General Statistically significant results will be defined as p<0.05 and trends as 0.05≤p<0.10. All analyses will be carried out using SPSS version 22 and Microsoft Office EXCEL 2013. Summary statistics Summary statistics will be produced for all baseline and outcome variables, as a complete dataset and for both baseline and outcome period. For variables measured on the interval or ratio scale, these will include: • Sample size (n) • Percentage non-missing • Mean • Variance / Standard Deviation • Range (Minimum / Maximum) • Median • Inter-quartile Range (25th and 75th percentiles) For categorical variables, the summary statistics will include: • Sample size (n) • Range (if applicable) • Count and Percentage by category (distribution)