A Post Marketing Survillance study ( EASE ) to study the efficacy & safety of Xolair ( Omalizumab) in IgE mediated Asthma.

• Register: CTRI
• Last refreshed on: 4 May 2013
• Main ID: CTRI/2010/091/000067
• Date of registration: 10-02-2010
• Primary sponsor: Novartis Healthcare Private Limited
• Public title: A Post Marketing Survillance study ( EASE ) to study the efficacy & safety of Xolair ( Omalizumab) in IgE mediated Asthma.
• Scientific title: Multi-center, open-label, non-comparative, clinical decision based Post-Marketing Surveillance (PMS) study for valuation of effic cy and afety of Xolair® (Omalizumab) in Ig mediated Asthma - EASE
• Date of first enrolment: 17-01-2010
• Target sample size: 50
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1283
• Study type: PMS
• Study design: Single Arm Trial; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label

Countries of recruitment

India

Contacts

• Name: Mangala Kotnis
• Affiliation: Novartis Healthcare Private Limited

• Name: Mangala Kotnis
• Affiliation: Novartis Healthcare Private Limited

Key inclusion & exclusion criteria

Inclusion criteria: 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%
Exclusion criteria: 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
the study.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Intervention1: Omalizumab: Dosage-Dose calculation as per serum IgE and Body weight of patient for 12 months (one vial of xolair contains 150mg of omalizumab)
Frequency-once or twice a month for 12 months as per investigators discretion
Route-Subcutaneous
Control Intervention1: NA: NA

Primary Outcome(s)

Evaluation of Clinically significant asthma exacerbations in patients with severe persistent

allergic asthmaTimepoint: at the end of 16, 28 & 52 week of treatment

Secondary Outcome(s)

1. Reduction in OCS use in patients

2.Number of days missed in work or collage

3.Use of other asthma maintenance medication / rescue medication 4.Worsening of asthma symptoms i.e. Hospitalization, emergency room visits and unscheduled

doctor visits

5. Lung function test will be assessed by FEV1, FVC & PEFR

6. Improvement in Asthma Control Score Questionnaires 7. Safety parameters along with serious adverse events 8. Global assessment by physicians & patients will be conductedTimepoint: at the end of 16, 28 & 52 week of treatment

Secondary ID(s)

CIGE025AIN01

Source(s) of Monetary Support

Novartis Healthcare Private Limited