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

Primary Purpose

Common Cold

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

ColdZyme® mouth spray

Placebo

About this trial

This is an interventional treatment trial for Common Cold

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

National Heart and Lung Institute, Imperial College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ColdZyme

Placebo

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Reduce the number of days with common cold symptoms

Reduce the number of days with virus present in oropharynx

Full Information

NCT ID

NCT02479750

First Posted

June 22, 2015

Last Updated

February 5, 2019

Sponsor

Enzymatica AB

1. Study Identification

Unique Protocol Identification Number

NCT02479750

Brief Title

Evaluation of ColdZyme® on Experimentally Induced Common Cold.

Acronym

COLDPREVII

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

March 23, 2016 (Actual)

Primary Completion Date

July 25, 2016 (Actual)

Study Completion Date

July 25, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Enzymatica AB

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Common Cold

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ColdZyme

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

ColdZyme® mouth spray

Intervention Type

Device

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Reduction of virus load

Description

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

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Reduce the number of days with common cold symptoms

Time Frame

11 days

Title

Reduce the number of days with virus present in oropharynx

Time Frame

11 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Patrick Mallia, MD

Organizational Affiliation

NHLI, Imperial College

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Heart and Lung Institute, Imperial College

City

London

ZIP/Postal Code

W2 1PG

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Evaluation of ColdZyme® on Experimentally Induced Common Cold.

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