Early Intervention With Leukotriene Receptor Antagonists in Patients With Grass Pollinosis: Effects on Clinical Symptoms and Allergic Inflammation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- The change of subjective AR symptoms
研究概览
简要总结
As many as 250 million people suffer from allergic rhinitis in China, which has a large population, early use of drugs may help better control the symptoms.This study aimed to investigate the effects of early interventional treatment with the leukotriene receptor antagonist (LTRA) montelukast on seasonal allergic rhinitis.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients showed distinct nasal symptoms (rhinorrhea, congestion, itching, and sneezing), and demonstrated sensitization to one of the grass pollen allergens (Artemisia, Chenopodium, and Humulus scandens) with an immunoglobulin (Ig) E ≥ 0.7 IU/mL, measured using the Pharmacia UniCAP system (Thermo Fisher Scientific China Co., Ltd., Shanghai, China).
- •had not received any therapies for AR or antibiotics for at least 4 weeks before their outpatient clinic visit prior to the study
- •all of the subjects in the study reside in Beijing.
排除标准
- •Patients diagnosed with bronchial asthma, suffering from rhinitis outside the pollen season, chronic sinusitis, deviated nasal septum, using specific immunotherapy, or participating in another drug efficacy trial during the 4-week period preceding the study.
- •pregnant women and minors
研究组 & 干预措施
Early interventional treatment group
The patients in this group:oral drug therapy from onset of the low pollen stage (August 1st, 2020) to the end of the pollen stage (September 30, 2020). Intranasal corticosteroids (mometasone furoate) from the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020).
干预措施: Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count. (Behavioral)
Post-onset treatment group
The patients in this group: oral drug therapy after the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020.). Intranasal corticosteroids (mometasone furoate) from the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020).
干预措施: Montelukast Sodium Tablets 10mg quaque die orally was administered after peak pollen count. (Behavioral)
Control group
The patients in this group:Intranasal corticosteroids (mometasone furoate) from the high pollen stage (August 14, 2020) to the end of the pollen stage (September 30, 2020).
干预措施: No oral drug therapy throughout the pollen period (Drug)
结局指标
主要结局
The change of subjective AR symptoms
时间窗: baseline, visit 1: 2 weeks prior to the high weed pollen stage, visit 2: high weed pollen stage, visit 3: 2 weeks after the high weed pollen stage.
Symptom change before and after treatment was estimated by Visual analogue scale(VAS) symptom score. The VAS symptom scores ranged from 0 (asymptomatic) to 10 (very severe). The questionnaire included nasal symptoms: nasal congestion, nasal discharge, sneezing, and rhinocnesmus; eye symptoms: lacrimation, eye itching, eye redness, swelling, and ophthalmodynia; airway symptoms: wheezing, chest constriction, cough, labored breathing.
次要结局
- The change of objective examination: nasal function(baseline, visit 1: 2 weeks prior to the high weed pollen stage, visit 2: high weed pollen stage, visit 3: 2 weeks after the high weed pollen stage.)
- The change of cytokine expression(baseline, visit 1: 2 weeks prior to the high weed pollen stage, visit 2: high weed pollen stage, visit 3: 2 weeks after the high weed pollen stage.)