Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Common Cold

Intervention / Treatment
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* Device: ColdZyme® mouth spray
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ColdZyme<br>ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. | Device: ColdZyme® mouth spray<br> <br> |
| Placebo Comparator: Placebo<br>Sugar based mouth spray manufactured to mimic ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. | Device: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in viral load in the URT | Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of symptomatic URTI (Upper Respiratory Tract Infection) | Reduction of number of days having a total symptom severity score of 6 or higher using a 5-graded Jackson scale, in relation to placebo. | 11 days | 
| Prevention of asymptomatic URTI. | Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab). | 11 days | 
| Fewer days with symptomatic URTI | The number of days with cold is defined as the sum of all days with a total score of ≥ 6 according to the modified method of Jackson. | 11 days | 
| Fewer days with asymptomatic URTI. | The number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline. | 11 days | 
| Lower level of proinflammatory proteins | Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha). | 11 days | 
| Lower daily total symptom score |  | 11 days | 
| Lower daily score of individual symptoms |  | 11 days |