Evaluation of ColdZyme® on Experimentally Induced Common Cold.

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.

Conditions
-----------------
Common Cold

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 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 (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.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ColdZyme<br>ColdZyme® mouth spray liquid. 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 liquid 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of virus load | 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 | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduce the number of days with common cold symptoms |  | 11 days | 
| Reduce the number of days with virus present in oropharynx |  | 11 days |