Therapeutic Role of Concomitant Intranasal Antihistamine and Corticosteroid in Patient With Perennial Allergic Rhinitis Whose Symptoms Are Not Controlled With Intranasal Corticosteroid
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- TNSS
研究概览
简要总结
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid for 2 weeks. After 2-week treatment, changes in clinical parameters including VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be evaluated.
详细描述
Patients with perennial allergic rhinitis whose symptoms are not controlled (visual analogue scale [VAS] ≥5) by 2-week treatment with intranasal corticosteroid will receive concomitant intranasal antihistamine and corticosteroid. In addition to VAS, total nasal symptom score (TNSS), total ocular symptom score (TOSS), rhinoconjunctivitis quality-of-life questionnaires (RQLQ) will be measured before treatment (baseline) and 2 week after treatment. The differences between parameters before treatment and those after 2-week treatment will be statistically analyzed using paired student t test, and p<0.05 was considered statistically significant.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Perinnial allergic rhinitis diagnosed by a doctor
- •Positive for one or more of inhalant perinneal allergen in skin prick test or serum specific IgE measurement
- •Age: 19 years or older
- •Allergic rhinitis symptoms not controlled (VAS ≥5) by 2-week treatment with intranasal corticosteroid
排除标准
- •Compliance for one or more drugs in last 2 weeks: <80%
- •Use of oral corticosteroid, oral or intranasal decongestant in last 2 weeks
- •Initiation of allergen-specific immunotherapy in last 12 months
- •Seasonal allergic rhinitis
- •Chronic rhinosinusitis other than allergic rhinitis
- •Nasal polyposis
- •Comorbid diseases including infectious, respiratory, cardiologic, renal, gastrointestinal, endocrinologic, oncologic, hemotologic and immunologic disorders which investigators judge to affect on the study significantly.
- •Patients' rejection
- •Pregenancy or lactation
研究组 & 干预措施
Active group
Patients with perennial allergic rhinitis who receive concomitant intranasal antihistamine and corticosteroid.
干预措施: concomitant intranasal antihistamine and corticosteroid (Drug)
结局指标
主要结局
TNSS
时间窗: 2 week
total nasal symptom score
次要结局
- TOSS(2 week)
- RQLQ(2 week)
- VAS(2 week)
研究者
Sangmin Lee, MD
Professor
Gachon University Gil Medical Center