A Non-interventional, Prospective Study With Benralizumab

Condition(s) studied

Study summary

This is a prospective, non-interventional, single-arm, multicenter study to investigate asthma control, and health-related quality of life (HRQL), lung function and asthma medication intake in severe eosinophilic asthma patients treated with benralizumab in a real-life setting in Germany.

Eligibility

Primary outcome measure(s)

• Change in Asthma Control Test (ACT) total score in patients from baseline to week 12, 24 and 52 after first benralizumab dose — From baseline to week 12, 24 and 52
  To assess asthma control in patients initiating treatment with benralizumab over time. The ACT includes 5 questions. The score can range from 5 (worst control) to 25 (best control). Scores between 20 and 25 indicate well-controlled asthma, and scores lower than 20 indicate patients with not-well controlled asthma.
• Proportion of responders at baseline, week 12, 24 and 52 after first benralizumab dose, using ACT — At baseline, week 12, 24 and 52
  To assess asthma control in patients initiating treatment with benralizumab. Responders are defined as patients with well-controlled asthma (ACT score ≥20).
• Change in daily doses of prescribed inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose — From baseline to week 12, 24 and 52
  To assess prescribed daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons.
• Change in daily doses of patient-reported inhaled corticosteroids (ICS) intake from baseline to week 12, 24 and 52 after first benralizumab dose — From baseline to week 12, 24 and 52
  To assess patient-reported daily ICS dose of benralizumab treated patients over time. Doses of medication will be converted to equivalents to be able to make comparisons.
• Reduction (in percentage) in prescribed daily ICS dose intake from baseline to week 52 after first benralizumab dose — From baseline to week 52
  To assess prescribed daily ICS dose of benralizumab treated patients with ICS dose reduction.
• Reduction (in percentage) in patient-reported daily ICS dose intake from baseline to week 52 after first benralizumab dose — From baseline to week 52
  To assess patient-reported daily ICS dose of benralizumab treated patients with ICS dose reduction.

Trial sites (41)

+ 1 more sites — see the full list on the official registry below.

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