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

NCT02522949 | Completed Results

• 1 other identifier: ENZY-001
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)

  11 days

• Prevention of Asymptomatic URTI

  11 days

• Fewer Days With Symptomatic URTI

  11 days

• Fewer Days With Asymptomatic URTI

  11 days

• Lower Level of Proinflammatory Proteins

  11 days

Study Arms (2)

ColdZyme

ACTIVE COMPARATOR

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

Device: ColdZyme® mouth spray

Placebo

PLACEBO COMPARATOR

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

Interventions

ColdZyme® mouth spray DEVICE

ColdZyme

Placebo DEVICE

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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 of serum neutralising antibodies against human rhinovirus16 at screening.
• Active allergic rhinitis, asthma or chronic obstructive pulmonary disease in last year.
• 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.
• Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
• Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
• Active autoimmune disease in last year.
• 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 until the end of study.
• 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.
• Participation in other clinical study within 60 days

Sponsors & Collaborators

• Enzymatica AB: lead

Related Links

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

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Due to the small sample size and the low infection rate of 76% and the power calculation being based on an estimated infection rate of \>85%, exploratory analyses of subjects who experienced an infection (subjects with a value of viral load above 0 in pharyngeal or nasal sample any time during the study period) were performed. Peak viral load turned out to be an unreliable parameter with sometimes two peaks for the same subject. Thus, viral load as AUC was analyzed in the post hoc analysis.

Results Point of Contact

• Title: Enzymatica AB
• Organization: Enzymatica AB

info@enzymatica.com

+46 46 286 31 00

Study Officials

• Cecilia Ahlström Emanuelsson, MD

  Otorhinolaryngology, Skåne University Hospital, Lund.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: August 13, 2015
• Study Start: March 1, 2013
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08