A Randomized Trial of Comparing a Combination of Montelukast and Budesonide With Budesonide in Allergic Rhinitis
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- The change of subjective AR symptoms
研究概览
简要总结
It is not proven unequivocally whether a combination of an intranasal corticosteroids (INS) and a cysteinyl leukotriene receptor antagonist has greater efficacy than INS in the treatment of severe allergic rhinitis (AR) . We performed a randomized, open-label study in 46 seasonal AR subjects receiving budesonide (BD, 256ug) plus montelukast (MNT, 10 mg) or BD alone (256ug) for 2 weeks. Visual analog scale (VAS) scores, nasal cavity volume (NCV), nasal airway resistance (NAR) and fractional exhaled nitric oxide (FeNO) were assessed before and at end of treatments as the primary treatment outcomes. Similarly, histamine, eosinophil cationic protein (ECP) and cysteinyl-leukotrienes (Cyslts) in nasal secretion and Th1/Th2 cells in nasal mucosa were evaluated as the secondary treatment outcomes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 47 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •moderate to severe seasonal allergic rhinitis
- •confirmed to had a diagnosis of SAR and also shown to be sensitized to mugwort allergen
- •had not received any therapies for AR or antibiotics for at least 7 days before their outpatient clinic visit prior to the study
排除标准
- •asthma (based on patient's history and pulmonary function tests)
- •had any other chronic disease
- •pregnant women
研究组 & 干预措施
combination of budesonide and montelukast
receive treatment with either a combination of budesonide (Rhinorcort Astra Zeneca AB), 1 spray per nostril twice daily (total 256 μg/d) and 10mg oral montelukast tablet (Merck Sharp & Dohme Australia Pty Ltd) in the evening for 14 days (BD+MNT treatment group)
干预措施: budesonide (Drug)
only intranasal budesonide
treatment with only intranasal budesonide 1 spray per nostril twice daily for 14 days (BD treatment group)
干预措施: budesonide (Drug)
结局指标
主要结局
The change of subjective AR symptoms
时间窗: at baseline, 14 days
The participants were asked by one investigator to fill in a questioner detailing the presence of nasal and eye symptoms (including nasal congestion, rhinorrhea, nasal itching, sneezing and eye itching), and to score each symptom on a 0-10 cm scale; with 0 cm = no symptoms and 10 cm = most severe and bothersome symptom. The same investigator calculated both the individual symptom and the average of the sum of 5 AR symptoms scores, before and at the end of 14 days' treatment. Any subject with a mean score of \< 4 cm at baseline was excluded from this study.
次要结局
- The change of objective examination: nasal patency(at baseline, 14 days)
- The change of Fractional Exhaled NO(at baseline, 14 days)
研究者
Luo Zhang
President,Beijing TongRen Hospital
Beijing Tongren Hospital