Specific Use-result Surveillance of Spiriva Respimat in asthmatics (patients with mild to moderate persistent asthma)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety 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-chronic obstructive pulmonary disease overlap syndrome

Population studied

• Short description of the study population:
  Patients with mild to moderate persistent asthma.
• 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-chronic obstructive pulmonary disease overlap syndrome patients
• Estimated number of subjects:
  180

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 mild to moderate persistent asthma under the real-world use.
• 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