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CTRI Number  CTRI/2022/04/041937 [Registered on: 19/04/2022] Trial Registered Prospectively
Last Modified On: 14/12/2022
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Drug 
Study Design  Single Arm Study 
Public Title of Study   Post marketing observational study in Allergic rhinitis (group of symptoms affecting the nose) and Urticaria (Hives) patients to know the effectiveness of Levocetirizine 
Scientific Title of Study   Post-marketing prospective, open label, single arm, two center, observational, study to assess the effectiveness of Levocetirizine in adult patients of Allergic rhinitis and Urticaria 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GGI- Levocetirizine-11-2021 Version 1.0 Dated 05 Nov 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories Ltd  
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad

Hyderabad
TELANGANA
500016
India 
Phone  04049048400   
Fax  04049048800   
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories Ltd  
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad


TELANGANA
500016
India 
Phone  04049048400   
Fax  04049048800   
Email  Rahul.Rathod@drreddys.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Rathod 
Designation  Head - Ideation and Clinical Research 
Affiliation  Dr Reddys Laboratories Ltd  
Address  Medical Affairs Department, Dr Reddys Laboratories Ltd, 7-1-27, Ameerpet, Hyderabad Hyderabad


TELANGANA
500016
India 
Phone  04049048400   
Fax  04049048800   
Email  Rahul.Rathod@drreddys.com  
 
Source of Monetary or Material Support  
Dr Reddys Laboratories Medical Affairs Department, Dr Reddy Laboratories Ltd, 7-1-27, Ameerpet Road, Ameerpet, Hyderabad Hyderabad TELANGANA 500016 India 
 
Primary Sponsor  
Name  Dr Reddys Laboratories 
Address  7-1-27, Ameerpet Hyderabad 500016 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Dabholkar Yogesh Gurudas  DY Patil Medical College and Hospital  Department of Otolaryngology, Dr DY Patil Medical College and Hospital, Nerul, Navi Mumbai, 400706
Mumbai (Suburban)
MAHARASHTRA 		 9967902777

ygsh@yahoo.com 
Dr Kiran Godse  DY Patil Medical College and Hospital  Department of Dermatology, Dr DY Patil Medical College and Hospital, Nerul, Navi Mumbai,400706
Mumbai (Suburban)
MAHARASHTRA 		 9322266687

kiran.godse@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
DY Patil Institutional Ethics Committee  Approved 
Hinduja Institutional Ethics Committe  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Notified 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L509||Urticaria, unspecified, (2) ICD-10 Condition: J308||Other allergic rhinitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Levocetirizine  Levocetirizine 5mg tablet. Administered orally as prescribed by physician for 7 days. 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  For Allergic Rhinitis
1. Male or female patients above 18 years of age with moderate-severe persistent or moderate-severe intermittent allergic rhinitis, and advised levocetirizine once daily evening treatment in routine clinical practice by treating physician
2. Present the general status of rhinitis as moderate or severe
3. Total nasal symptom scores greater than or equal to 6 points, with congestion.
4. One or more of the other symptoms present (itching, runny nose, and sneezing) with a score greater than or equal to 2 at the screening visit. For Urticaria:
1. Male or female patients above 18 years of age with chronic idiopathic urticaria (CIU) episodes of hives of characteristic wheal and flare appearance, occurring regularly, at least three times a week for a period of at least 6 weeks during the previous 3 months, without an identifiable cause.
2. Patients with at least 3 days of moderate or severe pruritus and wheals present at the start of the recruitment. 
 
ExclusionCriteria 
Details  For Allergic Rhinitis:
1. Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants.
2. History of alcohol abuse or illicit drug use
3. Pregnancy or risk of pregnancy and lactating patients
4. Known hypersensitivity to the Levocetirizine components used during the clinical trial
5. Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy
6. Concomitant use of potent topical corticosteroids.
For Urticaria:
1. Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants
2. History of alcohol abuse or illicit drug use
3. Participation in a clinical trial in the year before this study
4. Pregnancy or risk of pregnancy and lactating patients
5. Known hypersensitivity to the formula components used during the clinical trial
6. Other forms of urticaria, such as physical, drug-induced, acute, or cholinergic urticaria, had to be excluded.
7. Any systemic disease or dermatologic disease that would interfere with the evaluation of the symptoms.
8. Concomitant use of potent topical corticosteroids. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Effectiveness End points:
The following parameters will be assessed from Day 1 of the study till the end of the study.
Urticaria:
1. Frequency of wheals
2. Size of the wheals
3. Duration of Pruritus
4. Self-reported WPAI assessment during working days
Self-reported Stanford sleeplessness scale
Allergic Rhinitis: 1. Patient reported Reflective Total Nasal Symptom Score(TNSS) 2. Overall improved patient health related quality of life. 3. Self-reported WPAI assessment during working days 4. Self-reported Stanford sleeplessness scale 		 Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   20/04/2022 
Date of Study Completion (India) 01/07/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
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)?  

Response - NO
Brief Summary  
This study is an single-arm, two center, prospective Post-marketing study to evaluate the effectiveness of Levocetirizine in adult patients with Allergic rhinitis and Urticaria in 110 patients (> 18 years) that will be conducted in India. The endpoints will be frequency of wheals, Size of the wheals, Duration of Pruritus, Self-reported WPAI assessment during working days, Self-reported Stanford sleeplessness scale for Urticaria and Patient reported Reflective Total Nasal Symptom Score(TNSS), Overall improved patient health related quality of life, Self-reported WPAI assessment during working days  and Self-reported Stanford sleeplessness scale  for allergic Rhinitis in patients over the study period. The participants who were prescribed an evening oral dose of Levocetirizine before sleep daily for at least 7 days will be enrolled after assessing inclusion and exclusion criteria.
 
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