EUCTR2013-002163-26-SE进行中（未招募）不适用
A multicentre, randomised, double-blind, parallel group, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of benralizumab in asthmatic adults and adolescents inadequatley controlled on inhaled corticosteroid plus long-acting beta2 agonist (CALIMA) - CALIMA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,296
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent for study participation must be obtained prior to any study related procedures being performed (local regulations are to be followed in determining the assent/consent requirements for children and parent[s]/guardian[s]) and according to international guidelines and/or applicable European Union guidelines.
- •2. Female and male aged 12 to 75 years inclusively, at the time of visit 1. For those patients, who are 17 on the day of Visit 1 but will turn 18 after this day, will be considered an adolescent for the purposes of this trial.
- •3. History of physician diagnosed asthma requiring treatment with medium to high dose inhaled corticosteroids (greater than 250 microgrammes fluticasone dry powder formulation equivalents total daily dose) and a LABA for at least 12 months prior to visit 1
- •4. Documented treatment with inhaled corticosteroids and LABA for at least 3 months prior to visit 1, with or without oral corticosteroids and additional asthma controllers. The ICS and LABA can be parts of a combination product or given by separate inhalers. The ICS dose must be greater than or equal to 500 µg/day fluticasone propionate dry powder formulation or equivalent daily. For ICS/LABA combination preparations, the mid-strength approved maintenance dose in the local country will meet this ICS criterion.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 75
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1157
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 54
排除标准
- •1. Clinically important pulmonary disease other than asthma (e.g active lung infection, COPD, bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency, and primary ciliarydyskinesia) or ever been diagnosed with pulmonary or systemic disease, other than asthma, that are associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome)
- •2. Any disorder including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric or major physical impairement that is not stable in the opinion of the investigator and could affect the safety of the patient throughout the study, influence the findings of the study or their interpretations, or impede the patients ability to complete the entire duration of study.
- •3. Acute upper or lower respiratory infections requiring antibiotics or antiviral medicationwithin 30 days prior to the date informed consent is obtained or during the screening/run in period.
- •4. Any clinically significant abnormal findings in physical examination, vital signs, haematology, clinical chemistry or urinalysis during screening/run in period, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patients ability to complete the entire duration of the study.
研究者
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