Common ColdCOLDPREVIINCT02479750
Evaluation of ColdZyme® on Experimentally Induced Common Cold.
A study testing ColdZyme® mouth spray in people with Common Cold, run by Enzymatica AB at 1 site in United Kingdom.
Trial summary
This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally 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 16 to 70 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
- 88 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 23 Mar 2016to 25 Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy male or female subjects between 16-70 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
- Females of childbearing potential: shall 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 adhere to the prohibitions and restrictions specified in this protocol.
- 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 (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in two dilution.
- Active allergic rhinitis, asthma or chronic obstructive pulmonary disease during study period.
- Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
- Females: Pregnant, breast-feeding or intentions to become pregnant during the study.
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- 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.
- Use of any over the counter cold prophylaxis products such as ColdZyme®, C-vitamins, zinc or Echinacea within 1 month prior to the first administration of investigational product.
- Participation in other clinical trial with medical investigational product within 60 days prior to the first administration of investigational product.
- Hypersensitivity/allergy to any of the device ingredients
- Individuals with close contact to at risk patient group:
- infants (less than 6 months);
- the extremely elderly or infirm;
- pregnant women;
- patients with severe lung disease (asthma/cystic fibrosis (CF)/COPD);
- patients with immunosuppression.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Heart and Lung Institute, Imperial College
London, W2 1PG
About this study
Official title: Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.
This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally 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
88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.
- 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 | Experimental | ColdZyme® mouth spray liquid. 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 liquid 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 of virus load
The primary objective is to investigate the protective effect of ColdZyme® mouth spray against infection in the oropharynx by common cold virus (rhinovirus 16) in vivo in relation to placebo
Measured: 7 days
Secondary outcomes (2)
Reduce the number of days with common cold symptoms
Measured: 11 days
Reduce the number of days with virus present in oropharynx
Measured: 11 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study start23 Mar 2016
- Primary completion25 Jul 2016
- Study completion25 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymatica AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Mallia, MD, Principal investigator, NHLI, Imperial College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479750
- Sponsor's protocol ID
- ENZY-002
- Acronym
- COLDPREVII
- Status last verified
- Feb 2019
- First submitted
- 22 Jun 2015
- Last updated
- 7 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02479750
- Acronym / sponsor ID
- COLDPREVII / ENZY-002
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Enzymatica ABIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- 25 Jul 2016 (actual)
- Study completion
- 25 Jul 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Not posted in the source record
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 of common cold symptoms on experimentally 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
88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.
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 | Experimental | Device: ColdZyme® mouth sprayColdZyme® mouth spray liquid. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. |
| Placebo | Placebo comparator | Device: PlaceboSugar based mouth spray liquid 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
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects between 16-70 years. The investigator judges the definition of healthy by detailed medical history and physical examination.
- Females of childbearing potential: shall 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 adhere to the prohibitions and restrictions specified in this protocol.
- Perceived to have had at least one cold per year
Key exclusion criteria (17 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 (at screening) of serum rhinovirus 16 neutralising antibody titers at greater than or equal to one in two dilution.
- Active allergic rhinitis, asthma or chronic obstructive pulmonary disease during study period.
- Nasal disease, e.g. nasal polyposis, significant septal deviation, chronic rhinosinusitis, etc.
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 of virus load
Time frame: 7 days
The primary objective is to investigate the protective effect of ColdZyme® mouth spray against infection in the oropharynx by common cold virus (rhinovirus 16) in vivo in relation to placebo
2 secondary outcomes
Reduce the number of days with common cold symptoms
Time frame: 11 days
Reduce the number of days with virus present in oropharynx
Time frame: 11 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Common Cold
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Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
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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.
Patrick Mallia, MD principal investigator
NHLI, Imperial College
1 site in 1 country: see every site and its status.
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 at 1 site in United Kingdom.
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 17 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 7 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 of virus load (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 7 Feb 2019.