Preferences and consequences in therapy decision-making: tiotropium bromide plus olodaterol vs ICS-containing regimens in COPD patients in the Portuguese primary care setting: an observational, cross-sectional study (TIOLCOR Study)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Name of medicine, other:
  Spiolto Respimat
• Anatomical Therapeutic Chemical (ATC) code:
  (R01AD) Corticosteroids

  Corticosteroids
• Medical condition to be studied:
  Chronic obstructive pulmonary disease

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:
  300

Study design details

• Main study objective:
  To describe and compare the sociodemographic, anthropometric and clinical characteristics of COPD patients at the time of prescription of a new maintenance regimen with TIO/OLO or an ICS-containing regimen (free or fixed dose triple combination ICS/LABA/LAMA, LABA+ICS, LAMA+ICS, ICS monotherapy or other) in the Portuguese primary care setting.
• Outcomes:
  Demographic, anthropometric and clinical characteristics in the two study cohorts. Includes the number of patients for whom the new COPD treatment is in accordance with the GOLD 2019 Guideline recommendations, Patient symptomatology according to mMRC questionnaire and QoL according to EQ-5D-5L in the two study cohorts, Overall patient satisfaction with inhaler device according to a 5-point Likert scale and treatment satisfaction according to TSQM in the two study cohorts,
• Data analysis plan:
  All quantitative variables will be summarized using descriptive statistics. All qualitative variables will be summarized by absolute (n) and relative (%) frequencies. The statistical analysis will be performed through frequency tables for qualitative variables and tables with descriptive statistics for quantitative variables. A logistic regression will be used to explore the association between the dependent variable and independent variables of interest.