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
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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