Drug Use Investigation of ANORO ELLIPTA inhaler (200311)

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)
• 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:
  ANORO

Population studied

• Short description of the study population:
  This investigation will be conducted in patients who are first prescribed Anoro for the approved indication of the product, “Relief of symptoms of obstructive airway disorder due to COPD (chronic bronchitis and emphysema) (in the case that long-acting inhaled anticholinergic and long-acting inhaled beta2-agonist combination is required)”.
• Age groups:
  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

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  2000

Study design details

• Main study objective:
  This investigation will be conducted to collect and evaluate information regarding the safety and efficacy of ANORO ELLIPTA under the actual post-marketing use conditions of the product.
• Outcomes:
  Information regarding the safety and efficacy of ANORO 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