A regulatory required non interventional study to monitor the safety and effectiveness of once daily treatment of orally inhaled Vahelva Respimat (Tiotropium + Olodaterol fixed dose combination 2.5µg/2.5µg per puff (2 puffs comprise one medicinal dose)) for Korean patients with COPD (Chronic Obstructive Pulmonary Disease) (Vahelva Respimat regulatory Post-marketing Surveil)

Study type

• Study topic:
  Disease /health condition

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

  Safety study (incl. comparative)
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine, other:
  Vahelva Respimat
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  Patients aged 18 years or older diagnosed with chronic obstructive pulmonary disease received treatment with orally inhaled vahelva respimat under routine clinical practice in Korea.
• 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

  Renal impaired
• Special population of interest, other:
  Patients with chronic obstructive pulmonary disease
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  Outcomes pertaining to safety will be presented as incidence rates of adverse events
• Data analysis plan:
  Descriptive analysis will be performed.