Post marketing observational study in Allergic rhinitis (group of symptoms affecting the nose) and Urticaria (Hives) patients to know the effectiveness of Levocetirizine
- Conditions
- Health Condition 1: J308- Other allergic rhinitisHealth Condition 2: L509- Urticaria, unspecified
- Registration Number
- CTRI/2022/04/041937
- Lead Sponsor
- Dr Reddys Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 110
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Effectiveness End points: <br/ ><br>The following parameters will be assessed from Day 1 of the study till the end of the study. <br/ ><br>Urticaria: <br/ ><br>1. Frequency of wheals <br/ ><br>2. Size of the wheals <br/ ><br>3. Duration of Pruritus <br/ ><br>4. Self-reported WPAI assessment during working days <br/ ><br>Self-reported Stanford sleeplessness scale <br/ ><br>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 scaleTimepoint: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3) <br/ ><br>
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil