Multi-center, open-label, non-comparative, clinical decisionbased Post-Marketing Surveillance (PMS) study forvaluation of effic cy and afety of Xolair® (Omalizumab) inIg mediated Asthma
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Evaluation of Clinically significant asthma exacerbations in patients with severe persistent
研究概览
简要总结
This is an Prospective Open-label, Multi-centre, Non-Interventional, Non-Comparative, Clinical
Decision Based Post-Marketing Surveillance (PMS) Study, to collect the efficacy and safety data, for
Xolair
® (Omalizumab) therapy in Indian patients, who are symptomatic with high recommended doseof OCS & LABA. This study will not interfere with any therapeutic or diagnostic measures taken by the
treating physicians and patients will be recruited regardless of past or present therapeutic regimens.
Xolair
® is the first humanized antibody to be approved for the treatment of asthma in Europe, andrepresents a highly innovative approach to controlling the disease. In India it is approved for the
intended use in patients with severe-persistent asthma in adults and adolescents older than 12 years
of age.
The purpose of this open Label, Non-Comparative, Study is to evaluate the efficacy & safety of Xolair
®(Omalizumab), in a real day-to-day clinical practice in Indian population with IgE mediated asthma.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female, greater than or equal to 12 and less than or equal to 75 years of age
- •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%.
排除标准
- •A patient will be excluded from the study if he or she meets any of the following criteria at baseline:
- •Women who are pregnant, intending to become pregnant *or breastfeeding
- •Patients that have been treated with Xolair® in the past 18 months,
- •Severe medical condition(s) that in the view of the physician prohibits participation in the studye.g. severe renal or hepatic impairment
- •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 likehormonal contraceptives, IUD, and double-barrier contraception.
- •Acceptable methods ofcontraception may include total abstinence at the discretion of the investigator in cases where theage, career, lifestyle, or sexual orientation of the subject ensures compliance.
- •Reliable contraception should be maintained throughoutthe study.
结局指标
主要结局
Evaluation of Clinically significant asthma exacerbations in patients with severe persistent
时间窗: at the end of 16, 28 & 52 week of treatment
allergic asthma
时间窗: at the end of 16, 28 & 52 week of treatment
次要结局
- 1. Reduction in OCS use in patients(2.Number of days missed in work or collage)