Health Condition 1: null- All male & female pediatric and adolescents patients (age range 6 and 18 years) with moderate to severe persistent allergic asthma
Conditions
Interventions
Intervention1: Omalizumab (Xolair): Subcutaneous 125 mg per mL of omalizumab one or two injections of omalizumab per month depending on
weight & the baseline IgE levels of patient for 16 weeks
Sponsors
Novartis Healthcare Private limited
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| reduction in clinically significant asthma exacerbationsTimepoint: at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Reduction in OCS use 2.Reduction in Number of days missed in school or collage 3.Reduction in Use of other asthma maintenance & rescue medication 4.Reduction in Worsening of asthma symptoms 5.Improvement in Pediatric Asthma Quality of Life Questionnaire ( all visits) 6.Safety parameters along with serious adverse events.(all visits) 7.Global assessment by physicians & patientsTimepoint: 1.at baseline and at week 16. 2.at baseline and at week 16. 3.at baseline and at week 16 4.at week 16 5.all visits 6.all visits 7.at week 16. | — |
Countries
India
Contacts
Public ContactDr Mangala Kotnis
Novartis Healthcare Private Limited
Outcome results
None listed