Clinical trial NCT02479750: Evaluation of ColdZyme® on Experimentally Induced Common Cold.
Official title: Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Cold
Lead sponsor: Enzymatica AB
Sponsor class: INDUSTRY
First posted: 2015-06-24
Enrollment: 88
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Reduction of virus load
timeFrame: 7 days
Secondary outcomes:
measure: Reduce the number of days with common cold symptoms
timeFrame: 11 days
measure: Reduce the number of days with virus present in oropharynx
timeFrame: 11 days
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: National Heart and Lung Institute, Imperial College
Study officials:
affiliation: NHLI, Imperial College
name: Patrick Mallia, MD
role: PRINCIPAL_INVESTIGATOR
References: