Comparison Between Dexchlorpheniramine and Dexchlorpheniramine/Pseudoephedrine/Guaifenesin in the Relief of Allergic Symptoms in Rhinitic Patients With Viral Upper Respiratory Tract Infections and Productive Cough
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 170
- 主要终点
- Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
研究概览
简要总结
Patients with allergic rhinitis frequently present exacerbation of the atopic symptoms during viral infections of the upper respiratory tract. Also, allergic rhinitis makes the mucosa more reactive to infectious agents and potentiates mucus production.
The combination of dexchlorpheniramine, pseudoephedrine and guaifenesin elicits antihistaminic, decongestant and expectorant effects. The study hypothesizes is that this product is superior to dexchlorpheniramine alone in the relief of allergic symptoms and in promoting mucus elimination in atopic patients with viral infections of the upper respiratory tract.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with allergic rhinitis with symptoms of viral infection of the upper respiratory tract (rhinorrhea, nasal obstruction and productive cough)
- •Compliance of the subject to the treatment protocol
- •Agreement with the terms of the informed consent
- •Patients who did not use forbidden medications
排除标准
- •History of allergy to any component of the formulations
- •Use of any investigational drug within the last 30 days
- •Patients with bacterial infections of the upper respiratory tract
- •Patients with high blood pressure (> 140 x 90 mmHg)
- •Patients who are receiving inhaled beta-agonists or other antihistamine, decongestant or expectorant
- •Patients with known pulmonary disease (asthma, COPD, neoplasias)
- •Pregnancy
- •HIV + patients
- •Other conditions considered by the investigator as reasonable for non-eligibility
研究组 & 干预措施
Dexchlorpheniramine pseudoephedrine guaifenesin
干预措施: Dexchlorpheniramine, pseudoephedrine, guaifenesin (Drug)
Dexchlorpheniramine
干预措施: Dexchlorpheniramine (Drug)
结局指标
主要结局
Symptoms frequency and intensity evaluated with a 5 point visual analogic scale (VAS)
时间窗: 5 days
次要结局
- Subjective evaluation of efficacy and tolerability graded as excellent, good, fair ou poor.(5 days)