Encruse Ellipta Drug Use Investigation (201450)

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)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non interventional, Observational Post Marketing Surveillance under actual drug use condition.

Study drug and medical condition

• Name of medicine, other:
  Encruse ELLIPTA

Population studied

• Short description of the study population:
  This study was conducted in patients who were first prescribed Encruse for the approved indication, “relief of symptoms of obstructive airway disorder due to COPD (chronic bronchitis and emphysema)”.
• Age groups:
  • 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

  Other

  Pregnant women

  Renal impaired
• Special population of interest, other:
  Chronic obstructive pulmonary disease (COPD) patients
• Estimated number of subjects:
  1000

Study design details

• Main study objective:
  This investigation will be conducted to collect and evaluate information regarding the safety and efficacy of Encruse ELLIPTA under the actual post-marketing use conditions of the product.
• Outcomes:
  Information regarding the safety and efficacy of Encruse ELLIPTA under the actual post-marketing use conditions of the product.
• Data analysis plan:
  Items related to patient dispositionPatient demographic and baseline characteristicsItems related to safetyItems related to efficacy