Evaluation of ColdZyme® on Experimentally Induced Common Cold.

NCT ID: NCT02479750

Last Updated: 2019-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-23
• Study Completion Date: 2016-07-25

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ColdZyme

ColdZyme® mouth spray liquid. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.

Group Type: EXPERIMENTAL

ColdZyme® mouth spray

Intervention Type: DEVICE

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Interventions

ColdZyme® mouth spray

Intervention Type: DEVICE

Placebo

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymatica AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick Mallia, MD

Role: PRINCIPAL_INVESTIGATOR

NHLI, Imperial College

Locations

National Heart and Lung Institute, Imperial College

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

ENZY-002

Identifier Type: -

Identifier Source: org_study_id