In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 115
- 主要终点
- efficacy of H1 antihistamines (patients evaluation)
研究概览
简要总结
The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.
详细描述
Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.
We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.
Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.
The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.
Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •persistent allergic rhinitis
排除标准
- •the presence of asthma or nasal polyps,
- •acute and chronic upper respiratory infections,
- •administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.
研究组 & 干预措施
Desloratadine
patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks
干预措施: Desloratadine (Drug)
Levocetirizine
patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks
干预措施: Levocetirizine (Drug)
结局指标
主要结局
efficacy of H1 antihistamines (patients evaluation)
时间窗: 4 weeks
patients evaluation before and after 4-weeks treatment
次要结局
- asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)(1.5 years)
研究者
Stefan Cristian Vesa
Assistant professor
Iuliu Hatieganu University of Medicine and Pharmacy