Real-Life evaluation of asthma control and exacerbation risk in patients treated with fluticasone propionate / formotérol fixed-dose association (RealLiffe - FLT9507)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Study drug and medical condition

• Medicinal product name, other:
  Flutiform
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Estimated number of subjects:
  1225

Study design details

• Main study objective:
  Evaluate the proportion of patients with well-controlled asthma after 6 months treatment.
• Outcomes:
  asthma control evaluation using Asthma Control Questionnaire (ACQ5), Describe the clinical, spirometric and therapeutic profiles of patients
• Data analysis plan:
  The socio-demographic characteristics of the physicians participating in the study will be described and compared with the national population of specialist physicians to evaluate the representativeness of the sample. Summary statistics (mean, standard deviation, median and quartiles) will describe quantitative variables, and frequencies and percentages will describe qualitative variables and missing data. Comparisons will be made by analysis of variance for quantitative data and by Chi2 tests for qualitative variables.