Trelegy Ellipta general drug use investigation (asthma)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Observational Post-marketing surveillance

Study drug and medical condition

• Name of medicine:
  TRELEGY ELLIPTA
• Study drug International non-proprietary name (INN) or common name:
  FLUTICASONE FUROATE

  UMECLIDINIUM

  VILANTEROL TRIFENATATE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL08) vilanterol, umeclidinium bromide and fluticasone furoate

  vilanterol, umeclidinium bromide and fluticasone furoate
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  The objective of this investigation is to collect and assess information regarding the safety and effectiveness of Trelegy Ellipta in asthma patients under the actual use conditions.
• Outcomes:
  Information regarding the safety and effectiveness of Trelegy Ellipta in asthma patients under the actual use conditions.
• Data analysis plan:
  Patient characteristics, Occurrence of ADR (proportion and person-year), Proportion of responders in the overall assessment of effectiveness, Consideration of covariates by logistic regression model