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

• Medicinal product name:
  SPIOLTO RESPIMAT
• Anatomical Therapeutic Chemical (ATC) code:
  (R03AL06) olodaterol and tiotropium bromide

  olodaterol and tiotropium bromide
• 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:
  • 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

• Study design:
  Non interventional cohort study with follow up of 52 weeks. (Observational)
• Main study objective:
  Study to assess the long-term safety and effectiveness of Spilolto in Japanese patients with COPD in real-world setting.
• Setting:
  Number of study sites: 199 sites; Duration of observation: 52 weeks or until discontinuation of ; administration; Registration period: August 2016 to August 2017; Study period: August 2016 to November 2018
• 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.