Multicenter, openlabel, noncomparative, clinical decision basedpostmarketing surveillance (PMS) study forEvaluation of efficAcy and Safety of Xolair (Omalizumab)in IgE mediated Asthma in Pediatric patients
- Conditions
- Health Condition 1: null- All male & female pediatric and adolescents patients (age range 6 and 18 years) withmoderate to severe persistent allergic asthma
- Registration Number
- CTRI/2013/03/003478
- Lead Sponsor
- ovartis Healthcare Private limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1.Male or Female, 6 and 18 years of age
2. With inadequately controlled moderate to severe persistent allergic asthma (GINA Stage IV)
a. A positive Skin Prick Test or RAAST Test to greater than or equal to 1periennial aeroallergen, or strong clinical
history
b. IgE levels greater than or equal to 30 less er than or equal to 1500 IU per mL
c. Continuous treatment with high dose ICS plus LABA 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
1.Patients that have been treated with Xolair in the past 18 months.
2. Severe medical condition(s) that in the view of the physician prohibits participation in the study
e.g. severe renal or hepatic impairment
3. Known hypersensitivity to Xoalir (Omalizumab) or any of the components in the formulation
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method