PRAXIS - A real world longitudinal study of asthma and COPD in primary and secondary care

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cohort

  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Asthma

  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:
  11556

Study design details

• Main study objective:
  To identify different clinical phenotypes in a longitudinal real-world study of patients with asthma and COPD in primary care and hospitals setting. To study how health-related quality of life, disease control, exacerbations and mortality are affected by gender, treatment, multimorbidity and symptoms.
• Outcomes:
  Exacerbations, mortality, quality of life (using MiniAQLQ, CCQ or EQ5-DL) and disease control (ACT, CAT or mMRC). Treatment use. Use and interpretation of spirometry. Comorbidity among patients with asthma and COPD compared to a gender and age-matched reference population.
• Data analysis plan:
  Data processing is done in SPSS and STATA. Risk factors for primary outcome variables will be analyzed using various statistical methods such as logistic regression and Cox regression. For factors affecting health-related quality of life, multiple linear regression will be used. For data-driven cluster analysis, pam algorithm is used.

Documents

Study, other information

Publication list from the PRAXIS study group