- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02522949
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold (COLDPREV)
November 13, 2020 updated by: Enzymatica AB
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
Intervention / Treatment
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
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
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 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
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.
|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction in viral load in the URT
Time Frame: 7 days
|
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)
Time Frame: 11 days
|
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.
|
11 days
|
Prevention of asymptomatic URTI.
Time Frame: 11 days
|
Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab).
|
11 days
|
Fewer days with symptomatic URTI
Time Frame: 11 days
|
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.
Time Frame: 11 days
|
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
Time Frame: 11 days
|
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
Time Frame: 11 days
|
11 days
|
|
Lower daily score of individual symptoms
Time Frame: 11 days
|
11 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cecilia Ahlström Emanuelsson, MD, Otorhinolaryngology, Skåne University Hospital, Lund.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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 (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Actual)
November 16, 2020
Last Update Submitted That Met QC Criteria
November 13, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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