Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Reduction of virus load
研究概览
简要总结
This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally 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
88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.
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
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female subjects between 16-70 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
- •Females of childbearing potential: shall 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 adhere to the prohibitions and restrictions specified in this protocol.
- •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 (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in two dilution.
- •Active allergic rhinitis, asthma or chronic obstructive pulmonary disease during study period.
- •Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
- •Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
- •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.
- •Use of any over the counter cold prophylaxis products such as ColdZyme®, C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product.
- •Participation in other clinical trial with medical investigational product within 60 days prior to the first administration of investigational product.
- •Hypersensitivity/allergy to any of the device ingredients
- •Individuals with close contact to at risk patient group:
- •infants (less than 6 months);
- •the extremely elderly or infirm;
- •pregnant women;
- •patients with severe lung disease (asthma/cystic fibrosis (CF)/COPD);
- •patients with immunosuppression.
结局指标
主要结局
Reduction of virus load
时间窗: 7 days
The primary objective is to investigate the protective effect of ColdZyme® mouth spray against infection in the oropharynx by common cold virus (rhinovirus 16) in vivo in relation to placebo
次要结局
- Reduce the number of days with common cold symptoms(11 days)
- Reduce the number of days with virus present in oropharynx(11 days)