Characteristics of patients initiating Spiriva Respimat in Asthma in the UK: a cross-sectional study based on the Clinical Practice Research Datalink

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM BROMIDE
• Medical condition to be studied:
  Asthma

Population studied

• Age groups:
  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)
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  The main objective of the study is to describe the clinical and socio-demographic characteristics of asthma patients prior to the initiation of Spiriva Respimat for the treatment of Asthma within a general clinical population using the Clinical Practice Research Database (CPRD).
• Outcomes:
  The primary outcome is whether patient has Cardiac arrhythmias on the index date or in the year prior to the index date. The secondary outcome is whether patient has Cardiac failure on the index date or in the year prior to the index date.
• Data analysis plan:
  Patient characteristics will be tabulated and summarized for all new users of Spiriva Respimat. In addition, patient characteristics will be tabulated for the patients that initiated or switched to the other available treatments. Patient characteristics will be compared among patients who initiated Spiriva Respimat and patients in other treatment groups. Analyses will be conducted in unmatched cohorts and differences between Spiriva Restinmat and each of the other exposure groups will be assessed using absolute standardized differences (ASD),where an ASD of at least 10% will be considered a meaningful difference.