Common Cold
Conditions
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.
Interventions
DEVICEColdZyme® mouth spray
DEVICEPlacebo
Sponsors
Enzymatica AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of virus load | 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 |
Secondary
| Measure | 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 |
Countries
United Kingdom
Outcome results
None listed