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CTRI Number  CTRI/2023/10/058488 [Registered on: 10/10/2023] Trial Registered Prospectively
Last Modified On: 26/02/2024
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 to assess the effect of Fexofenadine plus Montelukast Tablets. 
Scientific Title of Study   “A Phase III, Prospective, Randomized, Double Blind, Active-Controlled, Comparative, Parallel Group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Fexofenadine 180 mg plus Montelukast 10 mg Tablets Versus Fixed Dose Combination of Fexofenadine 120 mg plus Montelukast 10 mg Tablets in Adult Patients with Severe Allergic Rhinitis.” 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CT/2023/27, Version No.: 00 and Dated Apr 24, 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajasekhara Reddy Tamma 
Designation  Managing Director 
Affiliation  Clinwave Research Pvt. Ltd. 
Address  Clinwave Research Pvt. Ltd., LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).

Hyderabad
TELANGANA
500062
India 
Phone  7989233379  
Fax    
Email  dr.sekhar@clinwave.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajasekhara Reddy Tamma 
Designation  Managing Director 
Affiliation  Clinwave Research Pvt. Ltd. 
Address  Clinwave Research Pvt. Ltd., LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).


TELANGANA
500062
India 
Phone  7989233379  
Fax    
Email  dr.sekhar@clinwave.co.in  
 
Details of Contact Person
Public Query  
Name  Mr Mihir Upadhyay 
Designation  Manager - Regulatory Affairs 
Affiliation  Exemed Pharmaceuticals 
Address  Exemed Pharmaceuticals, Plot No. 133/1 & 133/2, GIDC, Selvas Road, Vapi.

Valsad
GUJARAT
396195
India 
Phone  7405490368  
Fax    
Email  mihir.upadhyay@exemedpharma.com  
 
Source of Monetary or Material Support  
Exemed Pharmaceuticals, Plot No. 133/1 & 133/2, GIDC, Selvas Road, Vapi-396195, Gujarat, India. 
 
Primary Sponsor  
Name  Exemed Pharmaceuticals 
Address  Plot No. 133/1 & 133/2, GIDC, Selvas Road, Vapi-396195, Gujarat, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 12  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jilla Naganna  Gandhi Medical College and Hospital  In Patient Block, 3rd Floor, Department of General Medicine, Musheerabad, Secunderabad-500003.
Hyderabad
TELANGANA 		 9666345120

nagan99@gmail.com 
Dr Gondela Hari Krishna  Government ENT Hospital, Andhra Medical College  Department of ENT, Pedda Waltair, Visakhapatnam-530017.
Visakhapatnam
ANDHRA PRADESH 		 7382006743

drgharikrishnaresearch@gmail.com 
Dr Neeraj Gupta  Jawahar Lal Nehru (J.L.N) Medical College  Department of Pulmonary Medicine, Kala Bagh, Ajmer-305001.
Ajmer
RAJASTHAN 		 9829101942

drneerajajmer@yahoo.com 
Dr Manish Kumar Jain  Maharaja Agrasen Superspeciality Hospital  Clinical Research Room, Central Spine, Agrasen Aspatal Marg, Sector No. 7, Vidhyadhar Nagar, Jaipur-302039.
Jaipur
RAJASTHAN 		 9414414834

doctormanishjain2@gmail.com 
Dr Raja Bhattacharya  Medical College and Hospital, Kolkata  Department of Medicine, 4th floor, MCH Building, 88, College Street, Kolkata–700073.
Kolkata
WEST BENGAL 		 8777079509

rbrbhattacharya@gmail.com 
Dr Vijaykumar Bhagwan Barge  Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital  Department of Medicine, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur–416012.
Kolhapur
MAHARASHTRA 		 9011066766

rcsmgmc.research@gmail.com 
Dr Sagar Vivek Redkar  Redkar Hospital and Research Centre  Research Room, Mumbai-Goa Highway, Oxelbag, Dhargal, Tal-Pernem, Goa-403513.
North Goa
GOA 		 7969792769

redkardr.sagar@gmail.com 
Dr Shyam Narain Gupta  Sanjivini Hospital and Research Center  Research Room, CP-23 Viraj Khand, Near Hahnemann Chauraha, Gomati Nagar, Lucknow-226010.
Lucknow
UTTAR PRADESH 		 9415007110

smsdgupta@gmail.com 
Dr Rohan Patel  Sheth Vadilal Sarabhai General Hospital and Sheth Chinai Maternity Hospital  Research Room, Nr. Ellisbridge, Paldi, Ahmedabad-380006.
Ahmadabad
GUJARAT 		 9824499307

amdavadimail@tyahoo.co.in 
Dr Jayanta Kumar Panda  Sriram Chandra Medical College and Hospital  Department of General Medicine, CK 7 Medical College, Cuttack-753007.
Cuttack
ORISSA 		 9437028282

drjayantpanda@gmail.com 
Dr Narendra B Gadhiya  Surat Institute of Medical Science (SIMS)  Research Room, Beside Modh Vanik Vadi, Near Surat Railway Station, Laldarwaja, Katargam Road, Surat-395003.
Surat
GUJARAT 		 9925060025

lifecarehospital09@gmail.com 
Dr Konatham Rambabu  Visakha Institute of Medical Sciences (VIMS)  Department of Medicine, NH-16, Hanumanthavaka Junction, Visakhapatnam-530040.
Visakhapatnam
ANDHRA PRADESH 		 9177747328

drkrambaburesearch@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 12  
Name of Committee  Approval Status 
Institutional Ethics Committee Aatman Hospital (Sheth Vadilal Sarabhai General Hospital and Sheth Chinai Maternity Hospital)  Approved 
Institutional Ethics Committee for Human Research, Medical College and Hospital  Approved 
Institutional Ethics Committee, Gandhi Medical College/Gandhi Hospital  Submittted/Under Review 
Institutional Ethics Committee, Jawahar Lal Nehru Medical College  Approved 
Institutional Ethics Committee, King George Hospital (Government ENT Hospital)  Approved 
Institutional Ethics Committee, Maharaja Agrasen Superspeciality Hospital  Approved 
Institutional Ethics Committee, S.C.B. Medical College and Hospital  Approved 
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)  Approved 
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital, Kolhapur Institutional Ethics Committee 2 (RCSMGMCIEC2)  Approved 
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre  Submittted/Under Review 
Sanjivani Lung Centre Ethics Committee, Sanjivani Lung Centre (Sanjivini Hospital and Research Center)  Approved 
SIMS Ethics Committee, Surat Institute Of Medical Science  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J301||Allergic rhinitis due to pollen,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  FDC of Fexofenadine 120 mg plus Montelukast 10 mg Tablets  Patients will be advised to take one tablet once a day orally around the same time every day for 4 weeks. 
Intervention  FDC of Fexofenadine 180 mg plus Montelukast 10 mg Tablets  Patients will be advised to take one tablet once a day orally around the 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 or radio allegro sorbent test (RAST) to at least one relevant allergen and active symptoms of allergic rhinitis at screening or baseline visit.
3. Patients with visual analogue scale (VAS) score of 5 or more for total nasal symptoms and/or severe ocular symptoms at screening or baseline visit.
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening / baseline visit.
5. Patients with ability to understand and provide written, dated and signed informed consent form, which must have been obtained prior to screening.
6. Patients willing to comply with all the protocol requirements. 
 
ExclusionCriteria 
Details  1. Patients with hypersensitivity to either of the study medications or any of the ingredients of the formulation.
2. Patients with electrocardiographic abnormalities including conduction delay and an abnormal QTc interval.
3. Patients with upper respiratory tract infections including cold and systemic infections within 3 weeks of baseline or screening visit.
4. Patients with history of renal, hepatic, gastrointestinal tract, cardiovascular, respiratory, haematological, endocrine or neurological diseases.
5. Patients with clinically significant impaired hepatic function (SGOT and SGPT more than 2.5X the UNL) or renal dysfunction (serum creatinine ≥ 2.5 mg/dL).
6. Patients who had initiation of allergen immunotherapy within previous 6 months.
7. Patients with history of rhinitis medicamentosa, non-allergic rhinitis or substantial structural nasal obstruction.
8. Patients with history of nasal polyps or any clinically important nasal anomaly.
9. Patients with history of acute and/or chronic sinusitis within 30 days of baseline or screening visit.
10. Patients with history of eye surgery or intranasal surgery within 3 months of baseline or screening visit.
11. Patient with severe asthma requiring emergency room treatment within 1 month or hospitalization within 3 months before the trial.
12. Female patients who are pregnant or breast-feeding or expecting to conceive within the projected duration of the study.
13. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
14. Patients with uncontrolled hypertension with sitting systolic BP ≥ 160 mmHg and/or diastolic BP ≥ 100 mmHg at screening.
15. Patients with a history of any malignancy.
16. Patients with known case of infection with hepatitis B, hepatitis C or HIV.
17. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to screening visit.
18. Patients currently taking prohibited medications(s) listed and inability/unwillingness to discontinue them for the entire study period.
19. Suspected inability or unwillingness to comply with the study procedures.
20. Patients with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean change in visual analogue scale (VAS) score from baseline to end of the study visit for total nasal symptoms.  At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Day 28). 
 
Secondary Outcome  
Outcome  TimePoints 
Mean change in total nasal symptom score (TNSS) from baseline to end of the study visit.  At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Day 28). 
Mean change in total non-nasal symptom score (TNNSS) from baseline to end of the study visit.  At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Day 28). 
Mean change in total symptom score [TSS is the sum of total nasal symptom score (TNSS) and total non-nasal symptom score (TNNSS)] from baseline to end of the study visit.  At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Day 28). 
Adverse events & serious adverse events reported during the study.  Throughout the study. 
Changes in clinical laboratory parameters from baseline to end of the study visit.  At Baseline Visit (Visit 1) and
End of the Study Visit (Visit 5 / Day 28). 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/10/2023 
Date of Study Completion (India) 27/01/2024 
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   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

This trial is a phase III, prospective, randomized, double blind, active-controlled, comparative, parallel group, multicentric clinical study to evaluate the efficacy, safety and tolerability of fixed dose combination of Fexofenadine 180 mg + Montelukast 10 mg Tablets versus Fixed Dose Combination of Fexofenadine 120 mg + Montelukast 10 mg Tablets in adult patients with severe allergic rhinitis.

 

Patients who are willing and able to participate in the study will sign and date the informed consent form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give informed consent will be evaluated for all the eligibility criteria. Eligible patients aged between 18 and 65 years (both inclusive), with a history of allergic rhinitis, a positive skin prick test or radio allegro sorbent test (RAST) to at least one relevant allergen and active symptoms of allergic rhinitis at screening or baseline visit and visual analogue scale (VAS) score of 5 or more for total nasal symptoms and/or severe ocular symptoms at screening or baseline visit will be considered for the study.

 

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.

 

Patients will be assigned to either of the two arms i.e., Arm A or Arm B consisting of FDC of Fexofenadine 180 mg + Montelukast 10 mg Tablets or FDC of Fexofenadine 120 mg + Montelukast 10 mg Tablets. Patients will be advised to take one tablet once a day orally around the same time every day for 4 weeks. 
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