The Efficacy of Preseasonal Omalizumab Treatment in Seasonal Allergic Rhinitis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- the change of total nasal symptoms scores
研究概览
简要总结
Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR).
In recent years, biologics have become promising drugs for allergic diseases. The efficacy and safety of Omalizumab in treating SAR have been well proven by previous studies. However, the efficacy in preseasonal treatment for SAR has not yet been studied before.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients aged 18 to 60 years (inclusive).
- •With history of SAR for at least two years, with/without conjunctivitis and without asthma
- •Two or more nasal symptoms scores were ≥ 2 points during July - October in the last year.
- •Sensitised to common autumn pollens including sagewort and ragweed (a specific IgE level ≥ 3.5 kU/L).
- •Patients who have been informed of the nature and aims of the study and have given their written consent, willing to comply with the protocol.
- •Patients who are able to understand the information given and the consent and complete the daily record card.
排除标准
- •Patients with oral diseases/ allergies within the run-in period.
- •Patients accepted any kind of operations within 4 weeks of the run-in period.
- •Patients applied for systemic glucocorticoids within 4 weeks in the run-in period.
- •Patients with PAR.
- •Patients with any nasal condition that could confound the results of the study (chronic rhinitis, chronic rhinosinusitis with/without polyps).
- •Whatever the co-sensitization leading to clinically relevant AR, conjunctivitis or asthma likely to significantly change the symptoms of the patient throughout the study.
- •patients with comorbidity of severe asthma.
- •Patients applying beta-antagonist (local or systemic appliance).
- •Pregnant, breast-feeding / sexually active women of childbearing potential.
- •Patients treated with AIT for pollens within 3 years.
- •Participation in any clinical study within the 3 months of the run-in period.
- •Patients at risk of non-compliance..
- •Patients with immunologic suppression, diabetes mellitus, autonomic neuropathy, coronary heart disease or hypertension.
研究组 & 干预措施
omalizumab preseasonal treatment
For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season. Rescue medication could be used during pollen seasons.
干预措施: Omalizumab (Drug)
结局指标
主要结局
the change of total nasal symptoms scores
时间窗: at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
Rescue medication score
时间窗: at week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).
when the symptoms were very severe and could not tolerated, the patients could use loratadine as rescue medication. The need for rescue medication was assessed as rescue medication score (RMS), analyzed as the weekly sum of daily use of Loratadine (10mg/d, equivalent to 1 point) or nasal corticosteroid spray (2 points)
次要结局
- adverse events(one hour after injection in the Omalizumab group)
- the change of quality of life(at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).)
- eosinophilic indicators in nasal secretions(at baseline, week 2 (the initial phase of pollen season) , week 4(during the anticipated peak pollen phase), and week 6 (the end of season).)
研究者
Luo Zhang
President, Beijing TongRen Hospital
Beijing Tongren Hospital