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

Dr Reddys Laboratories1 个研究点分布在 1 个国家目标入组 110 人开始时间: 2022年4月20日最近更新: 2022年12月14日

试验速览

阶段: Unknown
状态: 已完成
发起方
入组人数: 110
试验地点: 1
主要终点: Effectiveness End points:

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•For Allergic Rhinitis
•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
•Present the general status of rhinitis as moderate or severe
•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:
•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.

排除标准

•For Allergic Rhinitis:
•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
•Pregnancy or risk of pregnancy and lactating patients
•Known hypersensitivity to the Levocetirizine components used during the clinical trial
•Participants dependent on decongestants (nasal or oral) or receiving allergen-specific immunotherapy
•Concomitant use of potent topical corticosteroids.
•For Urticaria:
•Participation in a clinical trial in the year before this study
•Known hypersensitivity to the formula components used during the clinical trial
•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.