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 topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medicinal product name:
  SPIRIVA RESPIMAT
• Medicinal product name, other:
  ICS/LABA, LTRA
• Study drug International non-proprietary name (INN) or common name:
  TIOTROPIUM BROMIDE
• Anatomical Therapeutic Chemical (ATC) code:
  (R03BB04) tiotropium bromide

  tiotropium bromide
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  The study population will be asthmatic patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA FDC, or initiated LTRA, or switched to a new ICS/LABA FDC from the previous ICS/LABA FDC in the UK during the study period (September, 2014-December 31, 2017).
• 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

• Study design:
  This study is a cross-sectional, non-interventional study based on existing data (NISed). The UK CPRD data will be used to assess the characteristics of asthma patients who were prescribed ICS/LABA FDC before the index date and who initiated Spiriva Respimat, or received a higher dose of ICS/LABA.
• 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).
• Comparators:
  Asthma patients who initiated a higher dose of ICS/LABA FDC, or LTRA, or alternatively those who switched from the previous ICS/LABA FDC to a new ICS/LABA FDC (for the secondary objective).
• 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.