| CTRI Number |
CTRI/2010/091/000067 [Registered on: 10/02/2010] |
| Last Modified On: |
12/03/2013 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
Type of Study
Modification(s)
|
Biological |
| Study Design |
Single Arm Study |
Public Title of Study
Modification(s)
|
A Post Marketing Survillance study ( EASE ) to study the efficacy & safety of Xolair ( Omalizumab) in IgE mediated Asthma. |
Scientific Title of Study
Modification(s)
|
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 |
| Trial Acronym |
EASE |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| CIGE025AIN01 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrAshok Mahashur |
| Designation |
|
| Affiliation |
|
| Address |
P.D.Hinduja National Hospital and Medical Research Center,
Pulmonary Medicine Department, Veer Sawarkar Marg, Mahim
Mumbai
MAHARASHTRA
400016
India |
| Phone |
02224449199 |
| Fax |
022-24440425 |
| Email |
dr_amahashur@hindujahospital.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Mangala Kotnis |
| Designation |
Medical advisor |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited, Sandoz House, 7th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
INDIA
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224958569 |
| Fax |
02224954112 |
| Email |
mangala.kotnis@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Mangala Kotnis |
| Designation |
Medical Advisor |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private limited
Sandoz House, 7th floor
Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
INDIA
Mumbai
MAHARASHTRA
400018
India |
| Phone |
02224958569 |
| Fax |
02224954112 |
| Email |
mangala.kotnis@novartis.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Novartis Healthcare Private Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Sandoz House, Shivsagar Estate
Dr. Annie Besant Road
Worli, Mumbai 400 018
INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Pramod.V. Niphadkar |
Asthma Allergy Center, Gurukripa, 1st Floor |
66 Hindu Colony Lane no-1, Dadar (E),-400014
Mumbai
MAHARASHTRA |
022-24105656
dr_niphadkar@vsnl.net |
| Dr.Parthasarathi Bhattacharya |
Institute of Pulmocare & Research |
CB-16, Salt Lake,-700064
|
033-23580424
parthachest@yahoo.com |
| DrDeepak Talwar |
Metro Centre for Respiratory Diseases |
Metro Centre for Respiratory Diseases,Metro Multispeciality Hospital,L-94, Sector-11, Noida- 201301
Gautam Buddha Nagar
UTTAR PRADESH |
01202522959
dtlung@hotmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Clinicom Dr Pramod Niphadkar |
Approved |
| Institutional Ethics Committee, Institute of Pulmocare & Research, Dr Parthsarthy Bhattacharya |
Approved |
| Metro Hosp & Heart Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Asthma, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| 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
Modification(s)
|
| Age From |
12.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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% |
|
| ExclusionCriteria |
| Details |
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. |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
Modification(s)
|
Not Applicable |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| 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
Modification(s)
|
| Outcome |
TimePoints |
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 conducted |
1. at baseline and 16, 28 & 52 week.
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. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
Phase of Trial
Modification(s)
|
Post Marketing Surveillance |
Date of First Enrollment (India)
Modification(s)
|
17/01/2010 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
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. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
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 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 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. |