Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Prescription event monitoring
Study drug and medical condition

Medicinal product name, other

Spiriva
Population studied

Age groups

  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Estimated number of subjects

10000
Study design details

Main study objective

To see the effectiveness of tiotropium compare to ICS/LABA in terms of prevention of COPD acute exacerbation and reducing incidence of pneumonia. The study will be conducted in a general practice setting, Korea National Health Insurance claim data & mortality data from the Bureau of Statistics, which includes computerized medical records of more than half million patients in South Korea

Data analysis plan

All analyses will be performed with SAS and R . All variables will be summarized descriptively through displays of mean(± standard deviations), median, and ranges for continuous variables, and frequency distributions of categorical variables. To address the imbalance of potential confounders between LAMA ICS/LABA groups, we matched treatment groups using propensity scores estimated as by multiple logistic regression analysis based on as age, sex, socioeconomics status, Charlson Comorbidity Index, and asthma, and history of COPD exacerbation. Cox proportional hazards regression analyses will be used to estimate hazard ratios (HRs) HRs and 95% confidence intervals (95% CIs) for all outcomes. For (possibly) repeating events (such as exacerbation event) additionally a Poisson regression model will be fitted for the number of events (taking into account the matching). Detailed methodology for summary and statistical analyses of data in this study will be documented in an SAP.