Aim of study
Therapeutic Frontiers is currently recruiting healthy (non-allergic, non-asthmatic, non-smoking) volunteers to help test the latest preventative mouth spray ColdZyme™ for efficacy against the common-cold.
Type of study
Common cold challenge study
Healthy male or female subjects between 16-70 years
Major Exclusion Criteria
Smoker, during the last 12 months
Any cold symptom within the last month
Presence (determined at screening) of RV16 neutralising ab titers.
Active allergic rhinitis, asthma or chronic obstructive pulmonary disease
Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
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
Central London (Screening -South Kensington and clinical visits – Paddington)
1x screening visit
5 x clinic visits (Fri, Mon, Wed, Fri, Mon) over a 10 day period
Screening blood draw (8mls) £40
Study visits (1 x 45 min – Fri, 4 x 15 mins – Mon, Wed, Fri, Mon) £375