The Efficacy Of Elonide Nasal Corticosteroids In Managing Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4
研究概览
简要总结
The aim of this clinical study is to compare the efficacy of Elonide Nasal Spray to Nasonex Nasal Spray and Placebo (non-active ingredient) in the management of allergic rhinitis.
There are two hypotheses of this study:
- Elonide nasal spray is same efficacy to Nasonex nasal spray.
- Elonide nasal spray is more efficient to placebo.
详细描述
There are several objectives of the study:
- To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via Quality of life assessments and nasal airflow improvements.
- To compare the efficacy of Elonide to Nasonex and Placebo in treating allergic rhinitis via symptomatics improvement.
- To assess the side effect of Nasal spray given.
Patients who meet the criteria to join the study will be randomized in a double-blind manner (patients and investigators). Patients will be given information about the study and consent form, patients will be randomized to 3 treatment group(Elonide, Nasonex, Placebo). Patients will be evaluated before and after treatment in one month time. Patients will be advised to use the nasal spray twice daily.
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
- Double (Participant, Investigator)
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
- •All adults patients 18 years and above
- •Newly diagnosed mild, moderate to severe, intermittent and persistent allergic rhinitis
- •Positive skin prick test or serum Immunoglobulin E
排除标准
- •Patients who have been on allergic rhinitis treatment
- •Below 18 years old
- •Patients diagnosed with asthma or immunodeficiency diseases
- •Pregnancy
- •Other concomitant rhinology disease
- •Severe deviated nasal septum
研究组 & 干预措施
Elonide Nasal Spray
Elonide is generic nasal spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray One pump for both nostrils twice daily
干预措施: Elonide Nasal Spray (Drug)
Nasonex Nasal Spray
Nasonex Aqueous Nasal Spray Dose: 50 mcg/dose mometasone furoate 140 sprays per nasal spray The usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total dose 200 micrograms) One pump for both nostrils twice daily
干预措施: Nasonex Nasal Spray (Drug)
Normal Saline
Placebo used is 0.9% sodium chloride Dose: 50 mcg/dose of 0.9% sodium chloride One pump for both nostrils twice daily
干预措施: Normal saline (Drug)
结局指标
主要结局
Change from Baseline in Symptoms Score on Allergic Rhinitis at Week 4
时间窗: Baseline and week 4
The Visual Analogue Score (VAS) is a validated, self-reported instrument assessing average scoring of overall allergic rhinitis symptoms in the last 7 days period from treatment date. Possible score range from 0 (no symptoms) to 100 (worst possible symptoms). Maximum number of change from baseline indicate improvement of symptoms. Change= (Baseline score - Week 4 score)
Mean difference from Baseline in Quality of Life Questionnaire on several domains at Week 4
时间窗: Baseline and week 4
Rhinoconjunctivitis Quality of Life Questionnaire (RQOLQ) contains several domains score to access patient quality of life for a 7 days period from treatment date. The domains include activities, sleep, non-hay symptoms, practical problems, nasal symptoms, eye symptoms and emotional. Possible scoring from 0 (not trouble) to 6 (extremely troubled). Change= (Baseline score - Week 4 score)
Change from Baseline in Total Nasal Resistance while normal breathing at Week 4
时间窗: Baseline and week 4
Total Nasal Resistance is performed using Rhinomanometry device that provides a functional measure if pressure during a breathing cycle. Normal values for total nasal resistance is below 0.2 and to 0.3 Pa cm3/s. Worst case will be higher than 0.3 Pa cm3/s indicate nasal obstruction. Change= (Baseline score - Week 4 score)
次要结局
- Adverse effect of Nasal Spray(Baseline to week 4)