NCT04648761进行中（未招募）不适用
OPTIMAL - Individualized Titration of Biologics in Severe Asthma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Comparison of proportions of patients with exacerbations aften one year in each group
研究概览
简要总结
OPTIMAL is a non-inferiority, open label randomized clinical trial thats investigates a titration algorithm for anti IL 5 biologics in severe asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed written consent
- •Age > 18 years
- •Correct asthma diagnosis as judged by (sub)-investigator
- •Treatment with anti-IL5/IL5r for 12 months or longer
- •Treatment with the same biologic drug in the last 12 months
- •No exacerbations requiring OCS in the last 12 months
- •Blood eosinophils < 0.30 in the last 12 months
- •No daily OCS for more than 3 days in the last 12 months with asthma as indication
- •Correct inhalation technique for using regular inhalers
- •Acceptable adherence to ICS (according to FMK as judged by (sub)-investigator)
排除标准
- •- Pregnant or breastfeeding females
- •Lack of effective contraception in women of childbearing potential who are sexually active with a non-sterilized male partner. Women of childbearing potential are defined as those who are not surgically sterile (e.g. bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Effective contraception is defined as intrauterine device (hormonal or non-hormonal), sexual abstinence, bilateral tubal occlusion, combined (estrogen and progesterone) hormonal contraception (oral, intravaginal and transdermal) and progesterone-only hormonal contraception (oral, injectable and implantable).
- •Previous medical history or evidence of an uncontrolled intercurrent illness such as but not limited to (e.g. Autoimmune disease, immunodeficiency, immunosuppression, malignant neoplastic conditions with current relevance) that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the algorithm or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidaemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to inclusion are eligible.
- •Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the algorithm or interpretation of subject safety or study results (eg. chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis polyangitiis, alpha-1-antitrypsin deficiency, Wegeners granulomatosis, Sarcoidosis).
- •Any clinically relevant abnormal findings in haematology or clinical chemistry (laboratory results from Visit 0), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject's ability to participate in the study.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
- •History of chronic alcohol- or drug abuse 12 months prior to inclusion
- •Concurrent enrolment in another clinical study involving an investigational treatment.
- •Use of immunosuppressive medication (eg, methotrexate, troleandomycin, oral gold, cyclosporine, azathioprine, intramuscular long-acting depot corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to inclusion and during the study.
研究组 & 干预措施
OPTIMAL group
Experimental
This group will have their anti IL 5 biologics titrated by OPTIMAL algorithm
干预措施: OPTIMAL algorithm (Biological)
Control group
No Intervention
This group will continue their treatment with anti IL 5 biologics unchanged
结局指标
主要结局
Comparison of proportions of patients with exacerbations aften one year in each group
时间窗: one year
次要结局
- Proportion of patients on reduced dose of biologics at the end of trial(One year)
研究者
Celeste Porsbjerg
Professor
Bispebjerg Hospital
研究点 (1)
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