Post marketing observational study in Allergic rhinitis (group of symptoms affecting the nose) and Urticaria (Hives) patients to know the effectiveness of Levocetirizine

Not Applicable

Completed

Conditions: Urticaria, unspecified, (2) ICD-10 Condition: J308||Other allergic rhinitis,

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.

Recruitment & Eligibility

Inclusion Criteria

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.
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.
Patients with at least 3 days of moderate or severe pruritus and wheals present at the start of the recruitment.

Exclusion Criteria

For Allergic Rhinitis: 1.
Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants.
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.
Participation in a clinical trial in the year before this study 4.
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.
Any systemic disease or dermatologic disease that would interfere with the evaluation of the symptoms.

Primary Outcome Measures

Name	Time	Method
Effectiveness End points:	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
The following parameters will be assessed from Day 1 of the study till the end of the study.	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
Urticaria:	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
1. Frequency of wheals	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
2. Size of the wheals	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
3. Duration of Pruritus	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
4. Self-reported WPAI assessment during working days	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
Self-reported Stanford sleeplessness scale	Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
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 Measures

Name	Time	Method

Locations (1): DY Patil Medical College and Hospital
🇮🇳
(Suburban), MAHARASHTRA, India
DY Patil Medical College and Hospital
🇮🇳(Suburban), MAHARASHTRA, India
Dr Dabholkar Yogesh Gurudas
Principal investigator
9967902777
ygsh@yahoo.com
Dr Kiran Godse
Principal investigator
9322266687
kiran.godse@dypatil.edu