Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Induced Rhinovirus Upper Respiratory Tract Infection in Healthy Volunteers. A Double-blind, Randomized, Placebo-controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 主要终点
- Reduction in Viral Load in the URT
研究概览
简要总结
This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation of induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.
详细描述
Common colds can be caused by a number of viruses, e.g. rhinoviruses, coronaviruses, influenza viruses and others. The majority of colds are however caused by rhinovirus infection, which is responsible for up to 80% of all common colds. This study evaluates the effect of creating a physical barrier on the pharyngeal mucosal membrane to prevent or reduce virus cell entry during common cold infection to reduce total virus load and common cold symptoms in vivo in relation to placebo.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between 18-65 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
- •Females of childbearing potential: should use reliable method of birth control. Reliable methods are hormonal contraceptives (combination pills, injections or implants), intrauterine device, condom or declared absence of sexual contact. Post-menopausal woman is defined as absence of menstrual discharge for at least two years.
- •Signed informed consent form prior to any study-related procedures.
- •Willingness and ability to complete the study.
- •Perceived to have had at least one cold per year.
排除标准
- •Smoker, during the last 12 months.
- •Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
- •Presence of serum neutralising antibodies against human rhinovirus16 at screening.
- •Active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year.
- •Positive for fur allergy (if subject is likely to come in contact with the specific pet) and/or dust-mite allergy in skin prick test at screening.
- •Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
- •Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
- •Active autoimmune disease in last year.
- •Evidence or history of drug or alcohol abuse.
- •Use of any prescribed or non-prescribed medication (except for contraceptives, paracetamol and ibuprofen) within 2 weeks prior to the first administration of investigational product until the end of study.
- •Use of any over the counter cold prophylaxis products such as C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product until the end of study.
- •Participation in other clinical study within 60 days
结局指标
主要结局
Reduction in Viral Load in the URT
时间窗: 7 days
Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo
次要结局
- Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)(11 days)
- Prevention of Asymptomatic URTI(11 days)
- Lower Level of Proinflammatory Proteins(11 days)
- Lower Daily Total Symptom Score(Day 0-10)
- Fewer Days With Asymptomatic URTI(11 days)
- Fewer Days With Symptomatic URTI(11 days)
- Lower Daily Score of Individual Symptoms(Day 10)