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1 Clinical Trial Details (PDF Generation Date :- Wed, 21 Nov :19:07 GMT) CTRI Number CTRI/2010/091/ [Registered on: 10/02/2010] - Last Modified On 12/03/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No PMS Biological Single Arm Trial A Post Marketing Survillance study ( EASE ) to study the efficacy & safety of Xolair ( Omalizumab) in IgE mediated Asthma. 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 Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) CIGE025AIN01 Protocol Number Details of Principal Investigator DrAshok Mahashur Phone Fax P.D.Hinduja National Hospital and Medical Research Center, Pulmonary Medicine Department, Veer Sawarkar Marg, Mahim dr_amahashur@hindujahospital.com Details Contact Person (Scientific Query) Mangala Kotnis Medical advisor Phone Fax , Sandoz House, 7th floor Shivsagar Estate Dr. Annie Besant Road Worli, INDIA mangala.kotnis@novartis.com Details Contact Person (Public Query) Mangala Kotnis Medical Advisor Novartis Healthcare Private limited Sandoz House, 7th floor Shivsagar Estate Dr. Annie Besant Road Worli, INDIA page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Phone Fax > Type of Sponsor NIL List of Countries of Principal Investigator Dr.Pramod.V. Niphadkar Dr.Parthasarathi Bhattacharya DrDeepak Talwar mangala.kotnis@novartis.com Source of Monetary or Material Support Primary Sponsor Details Sandoz House, Shivsagar Estate Dr. Annie Besant Road Worli, INDIA Pharmaceutical industry-global of Site Site Phone/Fax/ Asthma Allergy Center, Gurukripa, 1st Floor Institute of Pulmocare & Research Metro Centre for Respiratory Diseases 66 Hindu Colony Lane no-1, Dadar (E), CB-16, Salt Lake, N/A Metro Centre for Respiratory Diseases,Metro Multispeciality Hospital,L-94, Sector-11, Noida Gautam Buddha Nagar UTTAR PRADESH dr_niphadkar@vsnl.net parthachest@yahoo.co m dtlung@hotmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Clinicom Dr Pramod Niphadkar Approved 16/01/2010 Yes Institutional Ethics Committee, Institute of Pulmocare & Research, Dr Parthsarthy Bhattacharya Approved 13/01/2010 No Metro Hosp & Heart Institute Status Health Type Patients Approved 10/04/2010 No Date No Date Specified Condition Asthma Intervention / Type Details page 2 / 5

3 Comparator Agent Intervention 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 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Comparator Agent NA NA Age From Age To Gender Details Details Open Label Year(s) Year(s) Both 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. Primary Outcome Outcome Timepoints Evaluation of Clinically significant asthma exacerbations in patients with severe persistent allergic asthma at the end of 16, 28 & 52 week of treatment Secondary Outcome Outcome Timepoints 1. Reduction in OCS use in patients 1. at baseline and 16, 28 & 52 week. page 3 / 5

4 Target Sample Size Phase of Trial Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary 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 conducted Total Sample Size=50 Sample Size from =50 Post Marketing Surveillance 17/01/2010 No Date Specified Years=1 Months=0 Days=0 Open to Recruitment 2. at baseline and 16, 28 & 52 week. 3. at baseline and 16, 28 & 52 week. 4. at 16, 28 & 52 week. 5. at screening, 16, 28 and 52 week. 6. all visits 7. all visits 8. at 16 week, 28 week & 52 week. The results of this study are planned to be published in a renowned journal in order to provide information that may refine clinical practice and help improve outcomes achieved with Xolair (Omalizumab) therapy being studied. 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 n patients, who are symptomatic with high recommended dose of 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, and represents a highly innovative approach to controlling the disease. In it is approved for the page 4 / 5

5 Powered by TCPDF ( PDF of Trial 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 n population with IgE mediated asthma. page 5 / 5