Evaluation of ColdZyme® on Experimentally Induced Common Cold.

NCT02479750 | Completed

• 1 other identifier: ENZY-002
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Reduce the number of days with common cold symptoms

  11 days

• Reduce the number of days with virus present in oropharynx

  11 days

Study Arms (2)

ColdZyme

EXPERIMENTAL

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

Device: ColdZyme® mouth spray

Placebo

PLACEBO COMPARATOR

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.

Device: Placebo

Interventions

ColdZyme® mouth spray DEVICE

ColdZyme

Placebo DEVICE

Placebo

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Enzymatica AB: lead

Study Sites (1)

National Heart and Lung Institute, Imperial College

London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Patrick Mallia, MD

  NHLI, Imperial College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: June 24, 2015
• Study Start: March 23, 2016
• Primary Completion: July 25, 2016
• Study Completion: July 25, 2016
• Last Updated: February 7, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)