Evaluation of ColdZyme® on Experimentally Induced Common Cold.

Common Cold Clinical Trial

— COLDPREVII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479750
• Other study ID #: ENZY-002
• Status: Completed
• Phase: N/A
• Start date: March 23, 2016
• Est. completion date: July 25, 2016

Study information

• Verified date: February 2019
• Source: Enzymatica AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 25, 2016
• Est. primary completion date: July 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold

Intervention

Device:
• ColdZyme® mouth spray

• Placebo

Locations

Country	Name	City	State
United Kingdom	National Heart and Lung Institute, Imperial College	London

Sponsors (1)

Lead Sponsor	Collaborator
Enzymatica AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Reduce the number of days with common cold symptoms		11 days
Secondary	Reduce the number of days with virus present in oropharynx		11 days