A single-center, prospective, observational study on the effectiveness and safety of omalizumab in Chinese patients with moderate-to-severe allergic asthma in real-world clinical settings

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Single-center, prospective, observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  OMALIZUMAB
• Medical condition to be studied:
  Asthma

Population studied

• Short description of the study population:
  The study population included patients with moderate-to-severe allergic asthma received treatment with omalizumab under real-world clinical settings in China.
• Age groups:
  • Adolescents (12 to < 18 years)
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with allergic asthma
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To investigate the effectiveness of omalizumab among Chinese patients with moderate-to-severe allergic asthma in a real-world clinical setting
• Outcomes:
  The proportion of patients who had exacerbation during the first year following omalizumab initiation. 1. Oral or inhaled corticosteroid step-down, 2. Changes from baseline: Asthma control test, mini-AQLQ scores, forced expiratory volume in 1 second (FEV1), FeNO, and blood eosinophils.
• Data analysis plan:
  The proportion of patients who had exacerbation will be presented as the number and percentage. The corresponding 95% CI for the proportion will be calculated using Clopper-Pearson exact method. Bowker’s test examines the statistical difference in exacerbation between pre- and post-treatment periods of one year. Secondary analyses are descriptive. Mean ACT, FEV1, FeNO, and eosinophil counts at each study visit will be calculated. A post-hoc Tukey-Kramer HSD test will be used to perform multiple comparisons in the value between the baseline and each study visit.