iOUTRUN: Patient reported OUTcomes of Benralizumab in Real-world use in Severe EosiNophilic Asthma Patient
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 410
- 试验地点
- 14
- 主要终点
- The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment.
研究概览
简要总结
Asthma is a heterogeneous condition characterized by chronic inflammation of the pulmonary airways, with an estimated 300 million people currently affected worldwide and an increasing prevalence.
Eosinophils emerged as the hallmark of a prevalent type of severe asthma, which also involves T cells (T helper 2 (Th2) mainly, but also type 2 innate lymphoid cells) and was labeled the T2-high endotype. Benralizumab is a humanized IgG1κ monoclonal antibody.
It has been approved as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose ICSs plus a LABA.
Benralizumab (FASENRA®; AstraZeneca) was approved by healthcare authorities for adult severe eosinophilic asthma patients with a history of acute exacerbations in the past 12 months.
This study aims to generate real-world data on the characteristics of patients receiving benralizumab to assess early PRO parameters as well as long-term treatment effects in the Gulf cooperative council (Kingdom of Saudi Arabia, Kuwait, United Arab Emirates, Oman, and Qatar), Latin America (Brazil, Argentina, and Colombia), and India. It is anticipated that the data generated will provide practical, patient-focused real-world evidence and enhance communications between patients and physicians in an objective and structured manner to ensure better disease control in patients under benralizumab treatment
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or female patients aged 18 years or older with a physician’s confirmed diagnosis of severe eosinophilic, uncontrolled asthma.
- •Severe uncontrolled eosinophilic asthma requiring high-dose inhaled corticosteroid plus long-acting β adrenoceptor agonist as maintenance treatment.
- •Patients who have been prescribed but not yet initiated treatment with benralizumab (Fasenra®) according to local approved prescribing information prior to signed informed consent.
- •Provision of the signed written informed consent form (ICF) indicating that they understand the purpose of the study and procedures required for participation.
- •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
- •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).
- •Currently enrolled in an interventional clinical study except patients being in parallel documented in a national asthma registry
- •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.
- •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.
- •Women who are currently pregnant, breastfeeding, or lactating.
结局指标
主要结局
The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at eight weeks of benralizumab treatment.
时间窗: 8 Weeks
次要结局
- The changes from baseline in Asthma Control Questionnaire (ACQ-6) score at 1, 2, 3, 4, 24, and 56 weeks of benralizumab treatment.(- Percentage of patients with a total score improvement of ≥ 0.5 points (minimal clinically important difference [MCID]) in ACQ-6 at 1, 2, 3, 4, 8, 24, and 56 weeks of receiving benralizumab compared to baseline)