| CTRI Number |
CTRI/2022/09/045934 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
09/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Post Marketing Surveillance for Mepolizumab Auto-Injector |
|
Scientific Title of Study
|
An observational, 24 week, open-label, multi-center,
prospective post marketing surveillance study to evaluate the
safety, tolerability and patient treatment experience (PTE) of
mepolizumab administration via autoinjector for adult patients
aged 18 years or older suffering with severe eosinophilic
asthma. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 217046 Protocol Amendment 1 3rd Jan 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aanchal Gvalani |
| Designation |
Medical Advisor |
| Affiliation |
GlaxloSmithKline Pharmaceuticals Ltd |
| Address |
3rd Floor, Respiratory Division, Medical affairs
GlaxloSmithKline Pharmaceuticals Ltd.
GSK House,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
|
| Fax |
|
| Email |
aanchal.a.gvalani@gsk.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aanchal Gvalani |
| Designation |
Medical Advisor |
| Affiliation |
GlaxloSmithKline Pharmaceuticals Ltd |
| Address |
3rd Floor, Respiratory Division, Medical affairs
GlaxloSmithKline Pharmaceuticals Ltd.
GSK House,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
|
| Fax |
|
| Email |
aanchal.a.gvalani@gsk.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aanchal Gvalani |
| Designation |
Medical Advisor |
| Affiliation |
GlaxloSmithKline Pharmaceuticals Ltd |
| Address |
3rd Floor, Respiratory Division, Medical affairs
GlaxloSmithKline Pharmaceuticals Ltd.
GSK House,
Dr. Annie Besant Road,
Worli, Mumbai
Mumbai
MAHARASHTRA
400030
India |
| Phone |
|
| Fax |
|
| Email |
aanchal.a.gvalani@gsk.com |
|
|
Source of Monetary or Material Support
|
| GlaxoSmithKline Pharmaceuticals Ltd |
|
|
Primary Sponsor
|
| Name |
GlaxoSmithKline Pharmaceuticals Ltd |
| Address |
GSK House
Dr Annie Besant Road
Worli, Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zafar Ahmad |
Fortis hospital |
Fortis hospital , Mohali phase8, sector 62, Mohali 160062
Chandigarh
CHANDIGARH |
7508328879
Zafar.iqbal@fortishealthcare.com |
| Dr VV RamanaPrasad |
Krishna Institute of Medical Sciences (KIMS) |
1-8-31/1, Minister Rd, Krishna Nagar Colony, Ramgopalpet, Secunderabad, Telangana 500003
Hyderabad
TELANGANA |
9849991393
ramanaprasadpulmo@gmail.com |
| Dr A R Paramez |
Lisie Hospital |
Lisie Hospital, Department of Pulmonary Medicine, Kochi-682018, Kerela
Ernakulam
KERALA |
9526195777
drparamezar32@gmail.com |
| Dr Lakshmi Narasimhan Ramesh |
Manipal Hospital Mysore |
Manipal Hospital, Mysore,
No. 85-86, Bangalore-Mysore Ring Road Junction,
Bannimantapa A layout, Siddique Nagar, Mysuru, 570015, India
Mysore
KARNATAKA |
8872486735
lnarasimhan.1987@gmail.com |
| Dr Mahavir Modi |
Modi Clinic |
61A, RAKSHA LEKHA SOCIETY, DHANAKWADI, PUNE, maharashtra , india 411043
Pune
MAHARASHTRA |
9822253596
drm_modi@yahoo.co.in |
| Dr P C Kathuria |
National Allergy Centre |
National Allergy Centre, 1/3, East Patel Nagar Opp. Metro Pillar 181, New Delhi 11008
New Delhi
DELHI |
09312285947
pc_kathuria@yahoo.com |
| Dr V Nagarjuna Maturu |
Yashoda Hospital |
Yashoda Hospital, Raj Bhavan Road, Somajiguda, Hyderabad-500082, Telangana State
Hyderabad
TELANGANA
Hyderabad
TELANGANA |
9100935638
9100935638
arjunjipmer@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 10 |
| Name of Committee |
Approval Status |
| Ethics committee, Fortis Hospitals Limited, Faridabad |
Approved |
| Ethics committee, Fortis Hospitals Limited, Faridabad |
Approved |
| Good Society for Ethical Research |
Approved |
| IEC-Sai Sneh Hospital and Diagnostic Center |
Approved |
| Institutional ethics committee, Columbia asia hospital, Mysore |
Approved |
| Institutional Ethics Committee, Lisie Hospital, Kochi |
Approved |
| Krishna Institute of Medical Sciences (KIMS) Secunderabad |
Approved |
| Multi Speciality private Fortis hospital , Mohali phase8, sector 62, Mohali 160062 |
Approved |
| Naveneet Memorial hospital "SUSHRUSHA", Navrangpura, ahmedabad |
Approved |
| Yashoda Academy of Medical Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J82||Pulmonary eosinophilia, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from severe refractory eosinophilic asthma who have an indication from prescribing physician to start or have already started an add on treatment of mepolizumab by SC administration by patients or caregivers at home or healthcare providers in-clinic using a ready to use prefilled autoinjector |
|
| ExclusionCriteria |
| Details |
Patients with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes including Churg-Strauss Syndrome or
Eosinophilic Esophagitis Patients with a known pre existing parasitic infestation within 6 months prior to Visit 1 should be treated appropriately
before inclusion in the study
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
incidence of adverse events (AE),
serious adverse events (SAE) and adverse events
of special interest (AESI) |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Frequency and incidence of clinically
significant asthma exacerbations in the pre and
24-week post-exposure period with
mepolizumab treatment.
2. Frequency and incidence of clinically
significant asthma exacerbations requiring
ED visits and/or hospitalization (24 weeks pre
and post-exposure period).
|
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/10/2022 |
| Date of Study Completion (India) |
20/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The primary purpose of this post marketing, observational, prospective, real world study is the safety and tolerability of the subcutaneous administration of mepolizumab liquid drug product available as a ready to use prefilled autoinjector pen for patients 18 years or older, diagnosed with severe eosinophilic asthma. |