A Randomized, Double-blind, Prospective, Multicentric, Superior Efficacy and Safety of Naphazoline Hydrocloride + Pheniramine Maleate + Panthenol Compared With Naphazoline Hydrocloride in the Symptomatic Control of Nasal Congestion and Nasopharyngeal Due to Colds or Other Upper Respiratory Allergies
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 132
- 主要终点
- Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
研究概览
简要总结
The common cold is a major cause of nasal obstruction and reaches children and adults two or more times a year. At the moment, there is no cure for the common cold, and therefore the reduction of symptoms is the focus of the treatment.
The study has parallel distribution design, with two equal groups, in which one group will be treated by a combination of naphazoline hydrocloride + pheniramine maleate + panthenol and the other will receive treatment with naphazoline hydrocloride.
详细描述
STUDY DESIGN
- randomized,double blind, prospective, multicentric, parallel group, intent to treat trial
- Experiment duration: 3 days
- 2 visits (days 0 and 2)
- Evaluation of symptoms reduction
- Adverse events evaluation
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
- Triple (Participant, Care Provider, 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
- 否
入选标准
- •Patients must be able to understand the study procedures, agree to participate and give written consent.
- •Patients aged over 18 years of both sexes;
- •Patients with clinical signs of flu and colds or other upper respiratory allergies;
- •Patients with early signs and symptoms with time of evolution not more than 72 hours.
排除标准
- •Patients treated with antibiotics
- •Current treatment with immunosuppressants (eg.cyclosporine or methotrexate);
- •Use of intranasal cromalin the week before inclusion;
- •Use of decongestants or anti-histaminic (intranasal or systemic);
- •Presence of any disease or anatomical abnormality that may difficult the data analysis ;
- •Uncontrolled hypertension;
- •Presence of respiratory symptoms for more than 14 days;
- •History of abuse of drugs and alcohol;
- •Presence of other concomitant pulmonary diseases;
- •Hypersensitivity to any compound of investigational product
研究组 & 干预措施
Test group
Naphazoline Hydrocloride (1.0mg) + Pheniramine Maleate (0.2mg) + Panthenol(5.0mg).
02 drops in each nostril every 12 hours for 3 days
干预措施: Naphazoline hydrocloride + Pheniramine Maleate + Panthenol (Drug)
Comparator group
Naphazoline Hydrocloride (0.5mg)
02 drops in each nostril every 12 hours for 3 days
干预措施: naphazoline hydrocloride (Drug)
结局指标
主要结局
Efficacy of treatment in nasal congestion reduction based on Peak Flow Nasal Inspiratory (PFNI) assay
时间窗: 3 days
The individual response rate to the nasal congestion reduction is calculated by measuring the peak flow nasal inspiratory (PFNI) during the first and last visit.
次要结局
- Safety will be evaluated by the Adverse events occurence(3 days)