COPD, Bronchiectasis and Asthma Longitudinal Trends

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Chronic obstructive pulmonary disease

  Asthma

  Bronchiectasis

Population studied

• Short description of the study population:
  Adult population with COPD; Adult population with bronchiectasis; Adults and children with asthma; Adults with COPD-asthma overlap;
• Age groups:
  • Children (2 to < 12 years)
  • Adolescents (12 to < 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)

Study design details

• Study design:
  Non-interventional, multi-country, observational, retrospective cohort study based on secondary data
• Main study objective:
  Longitudinal trends in clinical outcomes among patients living with chronic respiratory diseases
• Setting:
  Non-interventional, multi-country, observational, retrospective cohort study based on secondary data from databases in France, Germany, the USA, and Japan. Selected study period is 2017 - 2024. ; The study will include patients who: are alive for at least one day during the study period (1 January 2017 to 31 December 2024) and have at least 12 months of continuous observation in the analysis set prior to their earliest qualifying diagnosis of each study condition (asthma, COPD, or bronchiectasis). Additionally, disease specific inclusion and exclusion criteria will be considered for each one of the cohorts
• Outcomes:
  Primary outcomes are annualized exacerbation rates, incidence of LRTI, and patients’ characteristics at baseline
• Data analysis plan:
  Four country-specific analysis sets will be defined, corresponding to the four contributing data sources: France, Germany, the United States, and Japan. Each analysis set will include all eligible patients from the respective data source.