Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(R03AL07) formoterol and glycopyrronium bromide
formoterol and glycopyrronium bromide
(R03AL06) olodaterol and tiotropium bromide
olodaterol and tiotropium bromide
(R03AL02) salbutamol and ipratropium bromide
salbutamol and ipratropium bromide
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

1800
Study design details

Main study objective

The primary objective is to understand the occurrence of COPD exacerbations in patients treated with LABA/LAMA in the routine clinical practice in Taiwan.The secondary objectives are to realize the clinical characteristics and prescription patterns for the COPD population in Taiwan.

Outcomes

• Time to the first moderate or severe COPD exacerbation, • Annualized rate of mild/moderate/severe exacerbation• Time/reason (e.g. severe airflow limitation, diagnosis of asthma, worsening exacerbation) from LABA/LAMA escalating to LABA/LAMA/ICS or from LAMA to dual therapy• Percentage of patients receiving LABA/LAMA switched to triple therapy or LAMA switched to dual therapy

Data analysis plan

A Data Validation Plan (DVP) will be prepared to describe the processes for data validation.The data abstracted from the medical chart will be described with number, mean, standard deviation (SD), range, and 95% confidence intervals (95% CI) for continuous variables, and frequencies and percentages for categorical variables.