Specific Use-result Surveillance of Spiriva respimat in asthmatics (patients with severe persistent asthma) (Specific Use-result Surveillance in asthmatics)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  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, observational study based on new data collection

Study drug and medical condition

• Medicinal product name:
  SPIRIVA RESPIMAT
• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM
• Anatomical Therapeutic Chemical (ATC) code:
  (R03BB04) tiotropium bromide

  tiotropium bromide
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  Patients aged ≥ 15 years old with severe persistent asthma who were naive to Spiriva respimat and receive Spiriva Respimat for the first time for the treatment of bronchial asthma on top of at least ICS treatment where safety of Spiriva® 2.5 µg Respimat® 60 puffs under the real-world use was not confirmed in clinical trials.
• 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:
  Asthma patients
• Estimated number of subjects:
  360

Study design details

• Study design:
  Non-interventional, observational study based on new data collection
• Main study objective:
  To investigate the safety and effectiveness of Spiriva Respimat in patients with asthma under the real-world use.
• Setting:
  Planned number of subjects: 360; Comparator product: Not applicable; Duration of treatment: 52 weeks
• Outcomes:
  The primary Outcome is the absolute and relative (%) frequency of patients with suspected adverse drug reactions (ADRs). Change from baseline in asthma control status
• Data analysis plan:
  To be analysed only descriptively