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
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
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.
结局指标
主要结局
Effectiveness End points:
时间窗: 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.
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
Urticaria:
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
1. Frequency of wheals
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
2. Size of the wheals
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
3. Duration of Pruritus
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
4. Self-reported WPAI assessment during working days
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
Self-reported Stanford sleeplessness scale
时间窗: 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
时间窗: Day 0 (Screening and enrollment) Day 1(V1), Day 3(V2) and Day 7 (V3)
次要结局
未报告次要终点