Evaluation of ColdZyme® on Experimentally Induced Common Cold. (COLDPREVII)

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

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.

Study Overview

• Status: Completed
• Conditions: Common Cold
• Intervention / Treatment: Device: Placebo; Device: ColdZyme® mouth spray

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.

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, W2 1PG
    • National Heart and Lung Institute, Imperial College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ColdZyme; 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 Comparator: 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.	Device: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
Reduce the number of days with common cold symptoms	11 days
Reduce the number of days with virus present in oropharynx	11 days

Collaborators and Investigators

• Sponsor: Enzymatica AB
• Investigators: Principal Investigator: Patrick Mallia, MD, NHLI, Imperial College

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2016
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): July 25, 2016

Study Registration Dates

• First Submitted: June 22, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimate): June 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 7, 2019
• Last Update Submitted That Met QC Criteria: February 5, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: ENZY-002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No