| CTRI Number |
CTRI/2019/10/021567 [Registered on: 09/10/2019] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical study of combination of Bilastine plus Montelukast in Patients with Allergic Rhinitis to know its effectiveness and side effects |
|
Scientific Title of Study
|
A Multicentric, Randomized, Double Blind, Parallel Group, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of FDC of Bilastine 20 mg plus Montelukast 10 mg Tablets Versus FDC of Levocetirizine 5 mg plus Montelukast 10 mg Tablets in patients with allergic rhinitis. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRPL/CT/19/011 |
Protocol Number |
| Version No. 00, Dated Jun 03, 2019 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raghumanda Sunil Kumar |
| Designation |
Professor & HOD of Pulmonology |
| Affiliation |
Government Medical College & Govt. General Hospital (Old RIMSGGH) |
| Address |
Department of Pulmonology, Government Medical College & Govt. General Hospital (Old RIMSGGH),
Srikakulam-532001, Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH
532001
India |
| Phone |
8942279033 |
| Fax |
|
| Email |
drsunilkumarrims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rahul Vij |
| Designation |
AGM - Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd.
Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi
New Delhi
DELHI
110087
India |
| Phone |
9999225948 |
| Fax |
|
| Email |
dra.domestic@synokempharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Rahul Vij |
| Designation |
AGM - Regulatory Affairs |
| Affiliation |
Synokem Pharmaceuticals Ltd. |
| Address |
Synokem Pharmaceuticals Ltd.
Drug Regulatory Affairs, Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi
DELHI
110087
India |
| Phone |
9999225948 |
| Fax |
|
| Email |
dra.domestic@synokempharma.com |
|
|
Source of Monetary or Material Support
|
| Synokem Pharmaceuticals Ltd. Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar,
New Delhi-110087, India |
|
|
Primary Sponsor
|
| Name |
Synokem Pharmaceuticals Ltd |
| Address |
Synokem Pharmaceuticals Ltd. Plot No. 14/486, Sunder Vihar, Outer Ring Road, Paschim Vihar, New Delhi-110087, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Swapnav Borthakur |
Down Town Hospital Ltd. |
Down Town Hospital Ltd.,
Dispur, G.S. Road, Guwahati-781006
Kamrup
ASSAM |
9864038704
swapnav.borthakur@gmail.com |
| Dr D Anil Kumar |
Gandhi Medical College / Hospital |
Department of General Medicine, Gandhi Medical College, Musheerabad, Secunderabad-500003
Hyderabad
TELANGANA |
9440523902
anilddrmd@gmail.com |
| Dr Raghumanda Sunil Kumar |
Government Medical College & Govt. General Hospital (Old RIMSGGH) |
Department of Pulmonology, Government Medical College & Govt. General Hospital (Old RIMSGGH),
Srikakulam-532001,
Andhra Pradesh, India.
Srikakulam
ANDHRA PRADESH |
8942279033
drsunilkumarrims@gmail.com |
| Dr Anand Kumar |
GSVM Medical College |
Department of Pulmonology,
GSVM Medical College, Swaroop Nagar,
Kanpur-208002,
Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH |
7860965384
dranandkumar.research@gmail.com |
| Dr Bijender Kumar Chhabra |
Maharaja Agrasen Superspeciality Hospital |
Department of Pulmonology, Maharaja Agrasen Superspeciality Hospital,
Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039, Rajasthan, India.
Jaipur
RAJASTHAN |
9314299576
agarsenhospital2003@gmail.com |
| Dr Sagar Vivek Redkar |
Redkar Hospital and Research Centre |
Department of Medicine, Redkar Hospital and Research Centre,
Mumbai-Goa Highway, Oshalbag, Village-Dhargal, Tal-pernem, Goa-403513, India.
North Goa
GOA |
9158592177
redkar.research@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Ethics Committee, Down Town Hospital |
Approved |
| Ethics Committee, G.S.V.M Medical College |
Approved |
| Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital |
Approved |
| Institutional Ethics Committee, Government Medical College & Government General Hospital (Old RIMS) |
Approved |
| Institutional Ethics Committee, Maharaja Agrasen Superspecialty Hospital |
Approved |
| Redkar Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J301||Allergic rhinitis due to pollen, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
FDC of Bilastine 20 mg plus Montelukast 10 mg Tablets |
One tablet once a day orally 1 to 2 hours before meals around same time every day for 4 weeks |
| Comparator Agent |
FDC of Levocetirizine 5 mg plus Montelukast 10 mg Tablets |
One tablet once a day orally 1 to 2 hours before meals around same time every day for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female patients aged between 18 and 65 years (both inclusive).
2. Patients with a history of allergic rhinitis, a positive skin prick test to at least one relevant allergen and active symptoms of allergic rhinitis at study entry.
3. Patients with Total Nasal Symptom Score (TNSS) at baseline ≥ 4. Baseline TNSS will be defined as the mean of the 6 last assessments of the patient’s diary (3 last days before randomization).
4. Patients with ability to understand and provide written informed consent form, which must have been obtained prior to screening.
5. Patients willing to comply with the protocol requirements. |
|
| ExclusionCriteria |
| Details |
1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Has clinical laboratory evaluations (including biochemistry and hematology) are not within the reference range for the testing laboratory and the results are deemed clinically significant by the investigator.
3. Patients with Electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
4. Patients with clinically significant impaired hepatic function. [SGOT & SGPT more than 2.5X the UNL and/or Total bilirubin more than 1.5X the UNL].
5. Patients with abnormal eGFR (<60 mL/min/1.73 m2).
6. Patients with Type 1 diabetes & Type 2 diabetes mellitus whose diabetes has not been stable and controlled for the previous three months and with HbA1c value greater than 8%.
7. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
8. Females who are not ready to use acceptable contraceptive methods during the course of study.
9. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline/screening visit.
10. Patients who had initiation of allergen immunotherapy within previous 6 months.
11. Patients with history of Rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
12. Patients with the presence of nasal polyps or any clinically important nasal anomaly.
13. Patients with the history of acute and/or chronic sinusitis within 30 days of baseline/screening visit.
14. Patients with the history of eye surgery or intranasal surgery within 3 months of baseline/screening visit.
15. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 month before the trial.
16. Patients with known case of HIV, Hepatitis B & C.
17. Patients with medical history of Oncological Conditions since last 5 years.
18. Patients with current evidence of clinically significant hematopoietic, cardiovascular, hepatic renal, neurologic, psychiatric, autoimmune disease, or other disease that precludes the patient’s participation in the study.
19. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent.
20. Currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
21. Suspected inability or unwillingness to comply with the study procedures. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The change in Total Symptom Score [(TSS is the sum Total nasal symptom score (TNSS) and Total Non-Nasal symptom score (TNNSS)] at the end of study as compared to baseline. |
At Day 7, Day 14 & Day 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The change in Total nasal symptom score (TNSS) at the end of study as compared to baseline. |
At Day 7, Day 14 & Day 28 |
| The change in Total non-nasal symptom score (TNNSS) at the end of study as compared to baseline. |
At Day 7, Day 14 & Day 28 |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
Final Enrollment numbers achieved (Total)= "212"
Final Enrollment numbers achieved (India)="212" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/10/2019 |
| Date of Study Completion (India) |
28/12/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
trial is a multicentric, randomized, double blind,
parallel group, comparative, phase III clinical study to evaluate the efficacy,
safety and tolerability of FDC of Bilastine 20 mg plus Montelukast 10 mg Tablets
Versus FDC of Levocetirizine 5 mg plus Montelukast 10 mg Tablets in patients with
allergic rhinitis.
After confirming
the inclusion/exclusion criteria the subject will be randomized and provided
with study medication at randomization visit. Subjects will be provided with patient
diary at randomization visit, which need to be brought along with in each
subsequent visit till the last visit. Follow up visits will be done on week 1/day
7(±1), week 2/day 14(±1) and week 4/day 28(±2) (Final Visit) of treatment to
assess efficacy, safety and tolerability. |