Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold (COLDPREV)

Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Induced Rhinovirus Upper Respiratory Tract Infection in Healthy Volunteers. A Double-blind, Randomized, Placebo-controlled Study

This study evaluates the performance of ColdZyme® mouth spray on prevention and alleviation of 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

Common colds can be caused by a number of viruses, e.g. rhinoviruses, coronaviruses, influenza viruses and others. The majority of colds are however caused by rhinovirus infection, which is responsible for up to 80% of all common colds. This study evaluates the effect of creating a physical barrier on the pharyngeal mucosal membrane to prevent or reduce virus cell entry during common cold infection to reduce total virus load and common cold symptoms in vivo in relation to placebo.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male or female subjects between 18-65 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
2. Females of childbearing potential: should 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.
3. Signed informed consent form prior to any study-related procedures.
4. Willingness and ability to complete the study.
5. Perceived to have had at least one cold per year.

Exclusion Criteria:

1. Smoker, during the last 12 months.
2. Any cold symptom within the last month such as sore throat, sneezing, rhinorrhoea, malaise, nasal obstruction or cough.
3. Presence of serum neutralising antibodies against human rhinovirus16 at screening.
4. Active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year.
5. Positive for fur allergy (if subject is likely to come in contact with the specific pet) and/or dust-mite allergy in skin prick test at screening.
6. Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
7. Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
8. Active autoimmune disease in last year.
9. Evidence or history of drug or alcohol abuse.
10. 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 until the end of study.
11. Use of any over the counter cold prophylaxis products such as C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product until the end of study.
12. Participation in other clinical study within 60 days

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
Active Comparator: ColdZyme; ColdZyme® mouth spray. 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 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 in Viral Load in the URT	Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo	7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)	Reduction of number of days having a total symptom severity score of 6 or higher using a 5-graded Jackson scale, in relation to placebo. Will be assessed by the severity of cold symptoms quantified by the modified method of Jackson at peak day (day with highest score). A subject is considered to be a success if the total symptom score is below 6. Otherwise will the subject be classified as a failure to prevent symptomatic URTI.	11 days
Prevention of Asymptomatic URTI	Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab). Will be assessed by quantification of viral load at peak day (day with highest viral load). A subject is considered to be a success if the viral load is not different from the base-line value (from day 0). Otherwise will the subject be classified as a failure to prevent asymptomatic URTI.	11 days
Fewer Days With Symptomatic URTI	The number of days with cold is defined as the sum of all days with a total score of ≥ 6 according to the modified method of Jackson.	11 days
Fewer Days With Asymptomatic URTI	The number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline.	11 days
Lower Level of Proinflammatory Proteins	Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha).	11 days
Lower Daily Total Symptom Score	Jackson score was used and the *mean* sum of the score is reported. Jackson score is based on the sum of 5 severity points in the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe), where 0 is minimum and 4 is maximum score, for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise.	Day 0-10
Lower Daily Score of Individual Symptoms	Mean (average) value of the participants' score per symptom on day 10 is reported, i.e. per symptom, the total sum of participants self-reported Jackson score from 0 to 4, divided with number of participants on day 10. The Jackson scale for eight cold symptoms is used in the rating, using the following scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe, 4 =very severe , where 0 is no symptom and 4 is maximum symptoms (worsed), for eight cold symptoms: sneezing, nasal obstruction, nasal discharge, sore throat, cough, headache, chilliness, and malaise.	Day 10

Collaborators and Investigators

• Sponsor: Enzymatica AB
• Investigators: Principal Investigator: Cecilia Ahlström Emanuelsson, MD, Otorhinolaryngology, Skåne University Hospital, Lund.

Publications and helpful links

Helpful Links

• Published article: A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Study on ColdZyme® Mouth Spray against Rhinovirus-Induced Common Cold

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimated): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 21, 2024
• Last Verified: August 1, 2024

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-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No