Biomarker Relatability in the International Severe Asthma Registry (BRISAR)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Medical condition to be studied:
  Asthma

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:
  6275

Study design details

• Main study objective:
  To assess the degree of overlap across commonly used asthma biomarkers of Type 2 inflammation (IgE, serum eosinophils and FeNO) among a diverse international cohort of severe asthma patients.To characterise and compare severe asthma patients positive for different combinations of asthma biomarkers as continuous and dichotomous variables.
• Data analysis plan:
  Patients will be classified according to each of 3 biomarkers: IgE, blood eosinophils andFeNO. Univariate distributions for demographics and clinical characteristics will be described for each of the biomarker groups. Categorical variables will be compared using Chi-squared statistics with p-values and presented as mean ± standard deviation. Continuous variables will be compared between biomarker groups via the independent samples t-test with p-values.Data reduction methods will be used to validate the clusters according to biomarker group using biomarkers as continuous variables (IgE, FeNO and serum eosinophils) to identify unique clusters in the ISAR cohort according to biomarker group status.Cluster analysis will then be used to group patients and the baseline characteristics of each group will be described.