A Pilot Study to Evaluate the Potential of Montelukast to Prevent the Development of Nasal Symptomatology During Natural Viral Upper Respiratory Infections
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Nasal Secretion Weights
研究概览
简要总结
Assesses the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years.
详细描述
This is a randomized double-blinded placebo controlled trial to assess the efficacy of treatment with montelukast 10 mg PO QD x 5 days versus placebo for the treatment of viral-induced upper respiratory infection in healthy adults aged 18-50 years. All subjects complete daily assessments of cold symptoms, nasal clearance rates and secretion rates during each day of the study. Phlebotomy is performed once for the determination of cytokine genotyping and allergy skin testing is performed once for the assessment of atopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18 to 50 years of age.
- •Male or female, who are not pregnant or lactating.
- •Common cold symptoms for less than 24 hours.
- •At least 2 of the following 9 symptoms: cough, headache, hoarseness, muscle ache, nasal drainage, nasal congestion, scratch throat, sneezing and malaise.
排除标准
- •Investigational medication in past 30 days.
- •Known hypersensitivity to any ingredients in study medication.
- •History of asthma or other chronic diseases.
- •Females of childbearing potential who are not using a medically acceptable form of birth control.
- •Patients with nasal ulcers within the past 1 month, nasal surgery within the past 6 months, nasal trauma within the past 2 months or presence of nasal polyps or nasal deformities causing significant nasal obstruction.
- •Females with a positive urinary HCG test.
- •Patients with a positive rapid antigen test for streptococcal infection.
- •Common cold symptoms for more than 24 hours.
- •Patients who are users of illicit drugs.
- •Patients who are on rifampin or phenobarbital.
研究组 & 干预措施
Montelukast
Treated for 4 months with montelukast 4 mg per day
干预措施: Montelukast (Drug)
Placebo
Treated for 4 months with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Nasal Secretion Weights
时间窗: 6 days after naturally acquiring an upper respiratory infection
次要结局
未报告次要终点
研究者
Deborah Gentile
Physician , Allergy and Asthma Institute
West Penn Allegheny Health System