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COLDPREVII: Evaluation of ColdZyme® on Experimentally Induced Common Cold.

Sponsor
Enzymatica AB (Industry)
Overall Status
Completed
CT.gov ID
NCT02479750
Collaborator
(none)
88
Enrollment
1
Location
2
Arms
4.1
Actual Duration (Months)
21.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ColdZyme® mouth spray
  • Device: Placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
88 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.
Actual Study Start Date :
Mar 23, 2016
Actual Primary Completion Date :
Jul 25, 2016
Actual Study Completion Date :
Jul 25, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Reduction of virus load [7 days]

    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

  1. Reduce the number of days with common cold symptoms [11 days]

  2. Reduce the number of days with virus present in oropharynx [11 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Heart and Lung Institute, Imperial College London United Kingdom W2 1PG

Sponsors and Collaborators

  • Enzymatica AB

Investigators

  • Principal Investigator: Patrick Mallia, MD, NHLI, Imperial College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Enzymatica AB
ClinicalTrials.gov Identifier:
NCT02479750
Other Study ID Numbers:
  • ENZY-002
First Posted:
Jun 24, 2015
Last Update Posted:
Feb 7, 2019
Last Verified:
Feb 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Common Cold

Study Results

No Results Posted as of Feb 7, 2019