A Double-blind,Double Dummy, Randomized, Multicenter Parallel-group Study on Efficacy of Desloratadine and Prednisolone Association Compared to Dexchlorpheniramine and Betamethasone Association in Adults With Moderate - Severe Persistent Allergic Rhinitis
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
研究概览
简要总结
The purpose of this study is to evaluate the non-inferiority clinical efficacy of two different drug associations in the treatment of Moderate - Severe Persistent Allergic Rhinitis in Adults.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed Consent of the patient;
- •Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
- •Adults aged ≥ 18 years old;
- •Evidence of sensitization to aeroallergens in examination (immediate skin tests or serum specific IgE) in the 12 months prior to inclusion.
排除标准
- •Decongestants dependent patients or patients receiving allergen specific immunotherapy;
- •Patients who were in use of oral antihistamines or decongestants in the past 15 days;
- •Patients who were treated with systemic corticosteroids in the last month;
- •Patients on treatment with monoamine oxidase inhibitors (MAOIs);
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Patients with any clinically significant disease that in the investigator opinion can not participate in the study
- •Patients who have uncontrolled asthma, chronic sinusitis, drug related rhinitis and nasal anatomic abnormalities.
- •Participation in clinical trial in 30 days prior to study entry;
研究组 & 干预措施
Desloratadine + Prednisolone
The patients will take 2 tablets three times a day, as follows:
Morning: 1 tablet of the test medication(Desloratadine 5 mg + Prednisolone 20 mg) + 1 tablet of placebo control medication.
Afternoon: 1 tablet of placebo test medication + 1 tablet of placebo control medication.
Night: 1 tablet of placebo test medication + 1 tablet of placebo control medication.
干预措施: Desloratadine + Prednisolone (Drug)
Dexchlorpheniramine + Betamethasone
The patients will take 2 tablets three times a day, as follows:
Morning: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Afternoon: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
Night: 1 tablet of the control medication(Dexchlorpheniramine 2mg + Betamethasone 0.25mg) + 1 tablet of placebo test medication.
干预措施: Dexchlorpheniramine + Betamethasone (Drug)
结局指标
主要结局
Efficacy of treatment in persistent allergic rhinitis based on nasal symptoms score
时间窗: 7 days
The mean variability of nasal symptoms score observed between visit 1 and visit 2 will be used as the primary endpoint of clinical efficacy.
次要结局
- Safety will be evaluated by the adverse events occurrences(7 days)