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

NCT ID: NCT02522949

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2013-06-30

Brief Summary

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.

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.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ColdZyme

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

Group Type: ACTIVE_COMPARATOR

ColdZyme® mouth spray

Intervention Type: DEVICE

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Interventions

ColdZyme® mouth spray

Intervention Type: DEVICE

Placebo

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Enzymatica AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cecilia Ahlström Emanuelsson, MD

Role: PRINCIPAL_INVESTIGATOR

Otorhinolaryngology, Skåne University Hospital, Lund.

Related Links

https://www.scirp.org/journal/paperinformation.aspx?paperid=79633

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

Other Identifiers

ENZY-001

Identifier Type: -

Identifier Source: org_study_id