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CTRI Number  CTRI/2021/02/031161 [Registered on: 09/02/2021] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Investigator Initiated Study to Evaluate Effect and safety of Bilazest (Bilastine 20mg) Tablets in Adult Patients with Allergic Rhinitis 
Scientific Title of Study   Prospective, Single Arm, Investigator Initiated Study to Evaluate Efficacy and safety of Bilazest (Bilastine 20mg) Tablets in Adult Patients with Allergic Rhinitis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Samir Bhargava 
Designation  ENT Surgeon 
Affiliation  Bhargava Nursing Home Surgical & General Hospital 
Address  Bhargava Nursing Home, Surgical & General Hospital, Gopal Bhuvan, Tagore Road, Santacruz (W), Mumbai, Maharashtra – 400054, India

Mumbai
MAHARASHTRA
400054
India 
Phone  9820055743  
Fax    
Email  drsamirbhargava@yahoo.co.in  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Yogesh Sharma 
Designation  Medical Director 
Affiliation  IDD Research Solutions Pvt Ltd 
Address  iDD Research Solutions Pvt. Ltd. 4th Floor, Ektha Serene, Located at 103/H | G-B & 104 / HIG-B Survey No.132, Gachibowli Housing Board Colony, Gachibowli, Hyderabad, Telangana-500095, India

Hyderabad
TELANGANA
500095
India 
Phone  9717832255  
Fax    
Email  yogesh@iddresearch.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Vairamuthu Ammaiyappam 
Designation  Associate Director 
Affiliation  IDD Research Solutions Pvt Ltd  
Address  iDD Research Solutions Pvt. Ltd. 4th Floor, Ektha Serene, Located at 103/H | G-B & 104 / HIG-B Survey No.132, Gachibowli Housing Board Colony, Gachibowli, Hyderabad, Telangana-500095

Hyderabad
TELANGANA
500095
India 
Phone  9606829331   
Fax    
Email  vairamuthu.ammaiyappan@iddresearch.com  
 
Source of Monetary or Material Support  
Bhargava Nursing Home Gopal Bhuvan 32 1st Floor Near Poddar School Tagore Rd Santacruz West Mumbai Maharashtra 400054 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [Registry] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 4  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samir K Bhargava  Bhargava ENT Clinic  Bhargava Nursing Home, Surgical & General Hospital, Gopal Bhuvan, Tagore Road, Santacruz (W), Mumbai, Maharashtra – 400054, India
Mumbai
MAHARASHTRA 		 9820055743

drsamirbhargava@yahoo.co.in 
Dr Hetal Marfatia  King Edward Memorial Hospital  Acharya Donde Marg Parel Mumbai 400012,ENT Dept, OPD Number 107
Mumbai
MAHARASHTRA 		 9820804402

drhetalent@gmail.com 
Dr Padmanabhan Karthikeyan  Mahatma Gandhi Medical College and Research institute  Pondicherry Cuddalore ECR Pillayarkuppam Puducherry 607402 1st Floor Hospital Block
Pondicherry
PONDICHERRY 		 9443381302

karthikent73@gmail.com 
Dr Chidananda Ramappa  Medstar Speciality Hospital  Medstar Speciality Hospital, #641/17/1/3, Kodigehaili Main Road, Sahakarnagar, Bangalore - 560092, karnataka, India
Bangalore
KARNATAKA 		 8041127524

medstarhospitalcr.crc1@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 4  
Name of Committee  Approval Status 
Institutional Ethics Committee of Aayush Hospital   Approved 
Institutional Ethics Committee- II  Submittted/Under Review 
Institutional Human Ethics Committee  Approved 
Medstar Speciality Hospital Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J988||Other specified respiratory disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria
Modification(s)  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patient willing and able to sign informed consent form.
2. Male & female patient between age group 18 years - 60 years
3. Patient with clinical history and presenting symptoms of Allergic Rhinitis who have not taken any medications for at least 2 weeks
4. Patient with no allergies to any of the ingredients of the study drug as per PI’s discretion
5. Patient willing to follow the protocols requirements 
 
ExclusionCriteria 
Details  1. Patient having hypersensitivity to Bilastine or any excipients of IP as per PI’s discretion
2. Patient with nasal polyps and deviation of the nasal septum or significant nasal tract structural malformation
3. Patient taking H1 or H2 antihistamines within 3 days to one week
4. Patient with acute or chronic sinusitis within 30 days of visit 1
5. Patient with a history of hypersensitivity to antihistamines, imidazole’s or lactose.
6. Patient taking corticosteroids during the last 4 weeks; loratadine or desloratadine during the last 10 days; anti-leukotrienes or ketotifen during the last 2 weeks; macrolides, imidazole, anticholinergics or decongestants during the last 3days; or immunotherapy within 2 years (unless taking a stable maintenance dose for 1 month) before entry into the study, any CNS acting agents including antidepressants,sedatives,anxiolytic,hypnotics, opioids or neuroleptics at any time
7. Patient with a history of alcohol and drug abuse
8. Patient with a history of smoking or tobacco use
9. Patient with any clinically significant condition (cardiovascular, neurological, upper
respiratory tract infection or acute/chronic pulmonary disorder, severe asthma or
malignant diseases)
10. Pregnant or nursing women
11. Patient who had participated in another trial within the previous 3 months
12. Patient with non-allergic rhinitis with different causes.
13. History of intranasal / eye surgeries within 3 months of Visit 1
14. Patient suffering from any other psychiatric illness or any other chronic disease which would interfere with trail assessments as per PI’s discretion 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the effectiveness of Bilazest (Bilastine 20 mg) tablet, in relieving the symptoms of allergic rhinitis in different geographical locations of India in terms of TSS  Change in total symptoms score (TSS) from baseline (Visit 1, D0) to Day 28 ( Visit 3, week 4) 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
To assess the safety of Bilazest (Bilastine 20 mg) tablet in relieving the symptoms of allergic rhinitis  Treatment emergent adverse event (TEAEs). 
To assess the effect of Bilazest (Bilastine 20 mg) tablet on Quality of life in AR patients  QOL assessed by the change in RQLQ (Rhino conjunctivitis quality of life questionnaire scores) from baseline (visit 1, Day 0) to day 7 (intermediate visit) and day 28 (visit 3, week 4) 
To assess the effect of Bilazest (Bilastine 20 mg) tablet in terms of NSS and NNSS  Change in NSS and NNSS scores from baseline Pre- medication to day 7
(intermediate visit) and day 28 (visit 3, week 4) 
To evaluate the psychodynamic effects of Bilazest (Bilastine 20 mg) tablet on the CNS by Stanford Sleeping Scale  Change in Stanford sleeping scale scores from pre-dose to 2 hours post-dose on day
0 (baseline visit) 
To assess the effect of Bilazest (Bilastine 20 mg) tablet on Liver function , kidney function & ECG  Change in the parameters for liver enzymes/ kidney function test/ ECG assessment from baseline to Day 28 (visit 3, week 4) 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   N/A 
Date of First Enrollment (India)
Modification(s)  		 20/03/2021 
Date of Study Completion (India) 10/02/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial
Modification(s)  		 Years="1"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 - 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  
This study is a prospective, Single Arm, Investigator Initiated Study to Evaluate Efficacy and Safety of Bilazest (Bilastine 20mg) Tablets in Adult Patients with Allergic Rhinitis. The rationale of the study is to observe and collect safety and effectiveness data on already approved and marketed Bilazest 20mg tablet containing Bilastine. If found to be successful, will provide an evidence to undertake a large-scale trials to improve long-term health outcomes for individuals with allergic rhinitis. Subjects will complete a screening visit (V1) to determine eligibility for the study based on Inclusion & Exclusion Criteria, medical history and safety measures. Study will be done approximately of 5 weeks (35 days) with 4 weeks (28 days) treatment period and 1 week (7 days) of follow
up period.The Primary Objective is to assess the effectiveness of Bilazest (Bilastine 20 mg) tablet, in relieving the symptoms of allergic rhinitis in different geographical locations of India in terms of TSS.
 
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