Back to resultsEvaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold (COLDPREV)
Primary Purpose
Common Cold
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ColdZyme® mouth spray
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ColdZyme
Placebo
Arm Description
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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).
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.
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.
Lower level of proinflammatory proteins
Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha).
Lower daily total symptom score
Lower daily score of individual symptoms
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02522949
Brief Title
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
Acronym
COLDPREV
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Enzymatica AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ColdZyme
Arm Type
Active Comparator
Arm Description
ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ColdZyme® mouth spray
Intervention Type
Device
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Reduction in viral load in the URT
Description
Reduction in viral load in the URT(Upper Respiratory Tract), after challenge with rhinovirus, in relation to placebo
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Prevention of symptomatic URTI (Upper Respiratory Tract Infection)
Description
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.
Time Frame
11 days
Title
Prevention of asymptomatic URTI.
Description
Asymptomatic URTI will be assessed by quantification of viral load at peak day (day with highest viral load measured by oropharyngeal swab).
Time Frame
11 days
Title
Fewer days with symptomatic URTI
Description
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.
Time Frame
11 days
Title
Fewer days with asymptomatic URTI.
Description
The number of days with asymptomatic URTI is defined as the sum of all days with a viral load significantly different from the baseline.
Time Frame
11 days
Title
Lower level of proinflammatory proteins
Description
Nasal samples will be analysed for the quantity of IL-6 (Interleukin 6), IL-8 and IFNα (Interferon alpha).
Time Frame
11 days
Title
Lower daily total symptom score
Time Frame
11 days
Title
Lower daily score of individual symptoms
Time Frame
11 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cecilia Ahlström Emanuelsson, MD
Organizational Affiliation
Otorhinolaryngology, Skåne University Hospital, Lund.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Links:
URL
https://www.scirp.org/journal/paperinformation.aspx?paperid=79633
Description
Published article: A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Study on ColdZyme® Mouth Spray against Rhinovirus-Induced Common Cold
Learn more about this trial
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
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