Post-marketing surveillance (PMS) on long-term use of tiotropium+olodaterol fixed dose combination (Tio+Olo FDC) 5/5µg in patients with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) in Japan (Japanese Spiolt PMS, long term)

Study type

• Study topic:
  Disease /health condition

  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:
  Cohort

  Other
• Non-interventional study design, other:
  Non-interventional, prospective, observational, single arm study

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

Population studied

• Short description of the study population:
  1. Patients who have been diagnosed with chronic obstructive pulmonary disease (chronic bronchitis, emphysema) by physician and need to be treated co-administration of a long-acting inhalational anticholinergic and a long-acting inhalational β2-agonist to relief of various symptoms associated with the obstructive impairment of airways; 2. Patients who were prescribed Tio+Olo FDC 5µg /5µg for the first time
• Age groups:
  Adolescents (12 to < 18 years)

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

Study design details

• Main study objective:
  Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with COPD in real-world setting.
• Outcomes:
  Incidence and exposure-time adjusted incidence rate of adverse drug reactions (ADRs). COPD assessment test (CAT) at 12 weeks.
• Data analysis plan:
  Descriptive statistics will be summarized for safety and efficacy. Incidence of adverse drug reactions.Change form baseline in COPD assessment test (CAT) at 12 weeks.Subgroup analyses.