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CTRI Number  CTRI/2013/07/003797 [Registered on: 04/07/2013] Trial Registered Prospectively
Last Modified On: 01/08/2019
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 trial to test the effectiveness of 2 drugs, a combination product {Ebastine (anti-histaminic or cold medication) plus Montelukast (anti-allergic medication)} in comparison with Ebastine (anti-histaminic or cold medication) in the treatment of patients with allergic rhinitis. 
Scientific Title of Study   A parallel group, randomized, double blind, multicentric, active controlled, phase III study comparing the safety and efficacy of Ebastine 10 mg with Montelukast 10 mg versus Ebastine 10mg in allergic rhinitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
MLB/02/2011, Version 5.0, dated: 23/08/2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Manjula 
Designation  Vice President, Medical Services 
Affiliation  Micro Labs Limited, Bangalore 
Address  27, Race Course Road, Bangalore

Bangalore
KARNATAKA
560001
India 
Phone  08022370451  
Fax    
Email  drmanjula@microlabs.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Krishna Kumar M 
Designation  Senior manager- Medical Services 
Affiliation  Micro Labs Limited 
Address  27, Race Course Road, Bangalore

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  krishna@microlabs.in  
 
Details of Contact Person
Public Query
Modification(s)  
Name  L Manjunath Reddy 
Designation  Manager - Regulatory Affairs 
Affiliation  Micro Labs Limited 
Address  27, Race Course Road, Bangalore

Bangalore
KARNATAKA
560001
India 
Phone    
Fax    
Email  raindia@microlabs.in  
 
Source of Monetary or Material Support  
Micro Labs Limited 
 
Primary Sponsor  
Name  Micro Labs Limited 
Address  27, Race Course Road, Bangalore 
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 = 13  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Bachi Hathiram   BYL Nair Hospital  Department of ENT BYL Nair Hospital, Mumbai central, Mumbai-400008
Mumbai (Suburban)
MAHARASHTRA 		 09004051418

orlclinics@gmail.com 
Dr Bimal Mondal  Calcutta National Medical College   Department of ENT Calcutta National Medical College and Hospital 32, Gorachand Road, Kolkata, West Bengal 700014
Kolkata
WEST BENGAL 		 033-22844834

dr.bmandalrkm@gmail.com 
Dr C V Srinivas  Dr. B.R Ambedkar Medical College  First floor, OPD block Department of ENT, Dr. B.R Ambedkar Medical College, Kadugondanalli, Bangalore- 560045
Bangalore
KARNATAKA 		 9845303344

game_sri@yahoo.com 
Dr Kailash N  Dr. B.R Ambedkar Medical College  First floor, OPD block Department of ENT, Dr. B.R Ambedkar Medical College, Kadugondanalli, Bangalore- 560045
Bangalore
KARNATAKA 		 09845155000

kaigaipraj@yahoo.com 
Dr Sunita Bage   Grant Government Medical College & Sir JJ group of Hospitals  Department of ENT,Main Building,3rd Floor Sir JJ group of Hospital and Grant Government Medical College Byculla Mumbai 400008 Mumbai MAHARASHTRA
Mumbai
MAHARASHTRA 		 91-9594757963

sunitabage123@gmail.com 
Dr Manmohan V Jagade  Grant Medical College & Sir J.J.Group of Hospitals  Department of ENT Grant Medical College & Sir J.J.Group of Hospitals-400 008 Mumbai
Mumbai (Suburban)
MAHARASHTRA 		 22-23735555

mohanjagade@hotmail.com 
Dr Chandregowda  Kempegowda Institute of Medical Sciences  First floor,OPD block Department of ENT, Kempegowda Institute of Medical Sciences Hospital & Research Center, K.R. Road,V.V puram, Banashankari 2nd stage Bangalore 560004
Bangalore
KARNATAKA 		 09845006520

dr.bvc@hotmail.co.in 
Dr Arunabha Chakravarti  Lady Hardinge Medical College  Department of ENT and Head & Neck Surgery, Lady Hardinge Medical College, New Delhi 110001
New Delhi
DELHI 		 09868093035

drchakravarti@yahoo.co.in 
Dr NVK Mohan  Medica Superspeciality Hospital  First floor, OPD-2 Department of ENT, Medica Superspeciality Hospital, 127 Mukandapur, EM bypass, Kolkata- 700099
Kolkata
WEST BENGAL 		 09748765775

nvkm68@hotmail.com 
Dr Subrata Mukhopadhyay  Medical College and Hospital, Kolkata  Department of ENT, 88, College Street, Kolkata- 700073
Kolkata
WEST BENGAL 		 09874262579

doct.subrata@gmail.com 
Dr A G Ghoshal  National Allergy Asthma Bronchitis Institute  11/3, Dr. Biresh Guha Street, 2nd Floor, IMA House Park Circus, Kolkata - 700017
Kolkata
WEST BENGAL 		 09830068023

agghosal@yahoo.com 
Dr Rajesh Avinash Chavan  Noble Hospital Pvt Ltd  Department of ENT Noble Hospital Pvt Ltd.l53, Magarpattacity road Hadpsar, pune 411013
Pune
MAHARASHTRA 		 09860031117

dnajchavan@gmail.com 
Dr Neeraj Mathur   Safdarjung Hospital  Department of ENT Safdarjung Hospital, Ring Road, Opposite AIIMS Hospital, Safdarjung West, Safdarjung Campus, Ansari Nagar East, New Delhi
East
DELHI 		 09811109637

drnnmathur@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 9  
Name of Committee  Approval Status 
Calcutta National Medical College  Approved 
Ethics commitee-Grant Medical College & Sir J.J.Group of Hospitals  Approved 
Ethics commitee-vardhman mahavir medical college safdarjung hospital  Approved 
Ethics committee-BYL Nair Hospital  Approved 
Ethics committee-Noble Hospital Pvt Ltd  Approved 
Institutional Ethics Committee, Dr. B R Ambedkar Medical College  Approved 
Institutional Ethics Committee, Dr. B R Ambedkar Medical College  Approved 
Institutional Ethics Committee, Kempegowda Institute of Medical Sciences  Approved 
Institutional Ethics Committee, National Allergy Asthma Bronchitis Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Allergic Rhinitis classified according to the International guidelines of ARIA,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ebastine  Ebastine is a 2nd generation anti-histaminc drug which is used in the treatment of allergic rhinits the formulation for Ebastine is an oral tablet containing 10 mg of active Ebastine which is given as a single daily oral dose for 6 weeks 
Intervention  Fixed dose combination of Ebastine & Montelukast  Ebastine is a 2nd generation anti-histaminic used in the treatment of allergic rhinitis. Montelukast is a leukotriene receptor antagonist used alone or in combination with anti-histaminc drugs in the treatment of allergic rhinits, & asthma The formulation is an oral tablet containing a fixed dose combination of ebastine 10 mg with Montelukast 10 mg given in a single daily oral dose for 6 weeks. 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Males and females of 12 – 65 years (inclusive)
2. Diagnosis of mild and moderate-severe persistent allergic rhinitis ( ≥ 4 days per week AND ≥ 4 weeks)
3. Able to provide informed consent to participate in the study (If minor [<18 years, consent from parent/legally authorized representative must also to be obtained in addition to the consent from the patient)
4. Ability to understand study procedures and to comply with them for the entire length of the study including able to record symptom scores in a diary (literate patients).
5. TSS baseline score of at least 5 after mean of 3 scores (based on investigator assessment)
6. Treatment naive for current episode of allergic rhinitis [If patient has already consumed more than 3 days’ doses of oral antihistamines for the current episode, then a wash-out of about 6-7 days to be given before administering study medication based on investigator discretion and patient willingness; if the patient consumes 1-2 doses of OTC cold medications for symptomatic relief, washout is not given.] 
 
ExclusionCriteria 
Details  1. Asthma patients
2. Subjects with a current history of frequent, clinically significant sinusitis or chronic purulent postnasal drip.
3. Subjects who, in the opinion of the investigator, are dependent on nasal, oral or ocular decongestants, nasal topical antihistamines or nasal steroids.
4. Any illness requiring steroid by any route.
5. Urticaria, Vasomotor rhinitis, Rhinitis medicamentosa.
6. Subjects who have, in the opinion of the investigator or designee, clinically significant nasal structural abnormalities, including large nasal polyps or marked septum deviation, that significantly interferes with nasal air flow.
7. Pregnancy or lactation.
8. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
9. Use of any other investigational drug in the last 90 days.
10. Subjects known to have an idiosyncratic reaction to any of the ingredients in IMP.
11. Subject with clinically significant abnormal vital sign or laboratory value that precludes participation.
12. Subjects with current evidence of clinically significant hematopoietic, cardiovascular,
hepatic, renal, neurologic, psychiatric, autoimmune disease, or other disease that
preclude the subjects participation in the study 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary Objective:
To compare the efficacy of Ebastine 10 mg plus Montelukast 10 mg with Ebastine 10 mg in decreasing the symptoms of allergic rhinitis for the first two weeks

Primary efficacy endpoint:
Change from baseline in the Total Symptom Score to the end of first two weeks of treatment 		 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Objective:
To compare safety of Ebastine 10 mg plus Montelukast 10 mg with Ebastine 10 mg when used for treatment of allergic rhinitis for 6 wks
Secondary efficacy endpoints:
Rhinoconjuctivitis QOL scale
Comparing sedation between 2 groups using VAS
Safety endpoint:
Comparison of safety parameters between Ebastine 10 mg plus Montelukast 10 mg and Ebastine 10 mg using lab parameters and adverse event profile as volunteered by patients and evaluated by the investigator 		 6 weeks 
 
Target Sample Size   Total Sample Size="552"
Sample Size from India="552" 
Final Enrollment numbers achieved (Total)= "541"
Final Enrollment numbers achieved (India)="541" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   15/07/2013 
Date of Study Completion (India) 02/06/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This clinical trial is a phase 3, randomised, parallel group, active controlled trial comparing the clinical efficacy, & safety profile of a fixed dose combination i.e. Ebastine with Montelukast versus Ebastine in patients with Allergic Rhinitis. 
The study duration is expected to be of 6 weeks, with 1 week follow up after the study. 

The clinical efficacy will be tested by the following parameters 
  • Total Symptom Score
  • Physician evaluation of signs of allergic rhinitis
  • Rhinoconjuctivitis Quality of Life scale
  • Comparing sedation between two groups using VAS
The safety of the drug(s) during the study will be monitored by adverse effect monitoring during patient visits or through telephonic information in between visits, & laboratory investigations. 
The compliance will also be monitored by pill-counting the left over medication during patient visits. 

 
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