Specific Use-result Surveillance of Spiriva Respimat in asthmatics (patients with mild to moderate 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:
  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, observational study based on new data collection

Study drug and medical condition

• 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

• 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