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 Laboratories0 个研究点目标入组 110 人开始时间: 待定最近更新: 2023年1月9日

试验速览

暂无简介。

•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.

发起方

Dr Reddys Laboratories