Multi-center, open-label, non-comparative, clinical decisionbased Post-Marketing Surveillance (PMS) study forvaluation of effic cy and afety of XolairÂ® (Omalizumab) inIg mediated Asthma - EASE

ovartis Healthcare Private Limited0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Male or Female, greater than or equal to 12 and less than or equal to 75 years of age
•2. Patients with inadequately controlled moderate-to-severe persistent allergic asthma (GINA Stage IV)
•a. Serum Allergy Test to greater than or equal to 1periennial aeroallergen
•b. IgE levels greater than or equal to 30 and less than or equal to 1500 IU per mL
•c. Continuous treatment with high-dose ICS plus LABA greater than or equal to 2 severe exacerbations per year
•d. Require more than 2 courses of oral corticosteroids in year
•e. Regular disruptive nocturnal or daytime symptoms as per GINA Stage IV
•f. FEV1 less than 70%

•A patient will be excluded from the study if he or she meets any of the following criteria at baseline:
•1. Women who are pregnant, intending to become pregnant *or breastfeeding
•2. Patients that have been treated with Xolair® in the past 18 months,
•3. Severe medical condition(s) that in the view of the physician prohibits participation in the study
•e.g. severe renal or hepatic impairment
•4. Known hypersensitivity to Xolair® (Omalizumab) or any of the components in the formulation
•*Intending to become pregnant will be advised medically approved birth control methods like
•hormonal contraceptives, IUD, and double-barrier contraception. Acceptable methods of
•contraception may include total abstinence at the discretion of the investigator in cases where the
•age, career, lifestyle, or sexual orientation of the subject ensures compliance. Periodic abstinence
•(e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not
•acceptable methods of contraception. Reliable contraception should be maintained throughout

发起方

ovartis Healthcare Private Limited