跳至主要内容
临床试验/CTRI/2023/03/051159
CTRI/2023/03/051159进行中(未招募)Unknown

iOUTRUN: Patient reported OUTcomes of Benralizumab in Real-world use in Severe EosiNophilic Asthma Patient - iOUTR

AstraZeneca Pharma India Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
进行中(未招募)

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

入选标准

  • 1. Male or female patients aged 18 years or older with a physician’s confirmed diagnosis of severe eosinophilic, uncontrolled asthma.
  • 2. Severe uncontrolled eosinophilic asthma requiring high-dose inhaled corticosteroid plus long-acting ß adrenoceptor agonist as maintenance treatment.
  • 3. Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.
  • 4. Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
  • 5. Patients must be able and willing to read and comprehend written instructions and complete the paper PRO questionnaires required by the protocol.

排除标准

  • 1. Clinically important pulmonary diseases other than asthma including chronic obstructive pulmonary disease (as the main diagnosis), bronchiectasis, idiopathic pulmonary fibrosis, pulmonary hypertension, alpha-1-antitrypsin-deficiency, and malignancy of any kind (NB: the following conditions are permitted: nasal polyposis, allergic rhinitis, atopic dermatitis, non-idiopathic pulmonary fibrosis).
  • 2. Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
  • 3. An acute or chronic condition that, in the investigator’s opinion, would limit the patients’ ability to complete questionnaires or participate in this study or impact the interpretations of results.
  • 4. Concurrent biologics for asthma are not allowed. Acceptable wash-out periods for other asthma biologics: =30 days from the last dose of the previous biologic.
  • 5. Women who are currently pregnant, breastfeeding, or lactating

研究者

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