Common ColdCOLDPREVNCT02522949
Evaluation of ColdZyme® Mouth Spray on Prevention and Alleviation of Rhinovirus Induced Common Cold
A study testing ColdZyme® mouth spray in people with Common Cold, run by Enzymatica AB.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- ColdZyme® mouth spray
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Mar 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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
About this study
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
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.
Read the 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
- Being tested
- ColdZyme® mouth spray, Placebo
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColdZyme® mouth sprayDevice
PlaceboDevice
| Study group | Role | What they receive |
|---|---|---|
| ColdZyme | Active comparator | ColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. Receives: 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. Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMar 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymatica AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cecilia Ahlström Emanuelsson, MD, Principal investigator, Otorhinolaryngology, Skåne University Hospital, Lund.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522949
- Sponsor's protocol ID
- ENZY-001
- Acronym
- COLDPREV
- Status last verified
- Aug 2024
- First submitted
- 1 Jul 2015
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02522949
- Acronym / sponsor ID
- COLDPREV / ENZY-001
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Enzymatica ABIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Aug 2015 (estimated)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ColdZyme | Active comparator | Device: ColdZyme® mouth sprayColdZyme® mouth spray. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. |
| Placebo | Placebo comparator | Device: PlaceboSugar 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColdZyme® mouth spray | Device | ColdZyme |
| Placebo | Device | Placebo |
Primary outcome
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 secondary outcomes
Prevention of Symptomatic URTI (Upper Respiratory Tract Infection)
Time frame: 11 days
Prevention of Asymptomatic URTI
Time frame: 11 days
Fewer Days With Symptomatic URTI
Time frame: 11 days
Fewer Days With Asymptomatic URTI
Time frame: 11 days
Lower Level of Proinflammatory Proteins
Time frame: 11 days
Lower Daily Total Symptom Score
Time frame: Day 0-10
Lower Daily Score of Individual Symptoms
Time frame: Day 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Published article: A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Study on ColdZyme® Mouth Spray against Rhinovirus-Induced Common ColdLink provided by the sponsor.
Related trials for Common Cold
Recruiting
Probiotic Trial for URTI Prevention in Healthy Adults
Upper Respiratory Tract Infections
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cecilia Ahlström Emanuelsson, MD principal investigator
Otorhinolaryngology, Skåne University Hospital, Lund.
Questions about this trial
What is this clinical trial studying?
A study testing ColdZyme® mouth spray in people with Common Cold, run by Enzymatica AB.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in Viral Load in the URT (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.