EUCTR2016-004315-13-Outside-EU/EEA进行中（未招募）1 期
Multicentric, Open-label, Randomized, Parallel-group Study to Evaluate the Efficacy and Safety of Omalizumab in a 12-MonthPeriod, in Patients with Severe IgE-mediated Asthma Inadequately Controlled with High Doses of Corticosteroids. MEXIC Study - MEXIC
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ovartis
- 入组人数
- 138
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
- •Inclusion Criteria
- •Male and female between 6 and 55 years old. If female, patient of childbearing potential must use a safe and efficacious birth control method.
- •Asthma is considered as not well-controlled if patient has 3 or more of the following conditions:
- •a.Persistent day symptoms with current therapy twice at week or more, (siblings, dyspnea, cough, chest pain, thoracic oppression).
- •b.One or more night-time awakenings over the last 4 weeks.
- •c.Any limitation of age-appropriated habitual activities.
- •d.Need of rescue medication (short acting ß2 agonist) for two or more occasions per week during the last 4 weeks before screening and 2 consecutives weeks within the 4 weeks before selection.
- •e.PEF or VEF1 <80% predicted or personal best (if known) this is not mandatory for pediatric patients (under 18 years old).
- •Despite continuous treatment with high-dose inhaled corticosteroids (ICS) or oral corticosteroids (OCS) (CSO= 1 mg/kg/day) with or without controllers (As per GINA 2012 definition), the subject is receiving high doses of ICS (budesonide or its equivalent) and a long-acting ß2-agonists(LABA) (formoterol) for the past 12 weeks at visit 0.
- •At last one documented asthma exacerbation (defined as increase asthma symptoms requiring systemic corticosteroid rescue therapy) that requires visits to the emergency room or to be hospitalized in the past 12 months. It is also considered asthma exacerbation a non-planned visit that required rescue medication (ß2-agonists and/or steroid nebulization every 20 minutes or ß2-agonists inhaler shots every 20 minutes).
- •Positive skin test or in vitro reactivity to a perennial aeroallergen, documented during the 12 months previous screening.
- •IgE total concentration ranging from 30 to 1500 UI/ml.
- •Body weight between 20 to 150 kg
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 42
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 95
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •Pregnant or lactating female or without safe and efficacious birth control method if of childbearing potential.
- •Currently smokers or history of smoking 10 or more packs per year.
- •Ex-smokers with a history of more than 10 years of smoking. As an exception, a patient with this criterion will be considered as eligible if the FEV1 reversibility of the first spirometry reaches 12%.
- •Active lung disease other than asthma.
- •Use of methotrexate, gold salts, troleandomycin, cyclosporine, immunosuppressants, gammaglobulin or any other type of monoclonal antibody used during the 6 months prior to the initial visit.
- •Use of omalizumab during the 4 months prior to de screening visit.
- •History of renal disease, cardiovascular disease, metabolic disease, hematologic disease, gastrointestinal disease, as well as immunodeficiency or cerebrovascular disease currently under treatment but not-controlled.
- •History of hepatic, neurologic, oncologic or autoimmune disease.
- •Patient under suspicion of having cancer.
- •Patients with history of hypersensitivity to sucrose, histidine, polysorbate 20 as well as to monoclonal antibodies or gammaglobulin.
- •Hypersensitivity to omalizumab or its excipients.
- •Abnormal values of the blood chemistry laboratory tests, over 2 times the upper limit normal, that are considered clinically significant.
- •Underage patient or any patient under vulnerable conditions who does not live with their parents or legal guardian.
研究者
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