Common ColdNCT03901846
Duration of ColdZyme® II
A study testing ColdZyme in people with Common Cold, run by Enzymatica AB at 1 site in Iceland.
Trial summary
The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM). Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Common Cold
- What is being tested?
- ColdZyme
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIceland
- Study dates
- 7 May 2019to 25 Jul 2019
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects between 18-70 years. The investigator judges the definition of healthy by medical history.
- No reported symptoms of sore throat.
- Readiness to comply with trial procedures.
- Females of childbearing potential: should use reliable method of birth control.
- Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Who cannot join
- Known allergy or hypersensitivity to the components of the investigational product
- History and/or presence of clinically significant condition/disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject.
- Any current cold symptom such as sore throat, sneezing, rhinorrhea, malaise, nasal obstruction or cough.
- Use of products, drugs, or food containing glycerol that may influence the study outcome, or concomitant medication with pharmaceuticals that might cause dry mouth (xerostomia), e.g. but not restricted to, morphine or morphine derivates, diuretics, antidepressants or other drugs with anticholinergic effect.
- Females: Pregnant or breast-feeding
- History of (in the past 12 months prior to study start) or current abuse of drugs, alcohol or medication
- Inability to comply with study requirements according to investigator's judgement
- Participation in another clinical study in the 30 days prior to enrolment and during the study
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).
Read the detailed description
The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.
- Conditions
- Common Cold
- Being tested
- ColdZyme
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColdZymeDevice
ColdZyme is a Class I medical device (CE-marked) with the following composition: glycerol, water, Tris buffer, CaCl2, menthol and trypsin
| Study group | Role | What they receive |
|---|---|---|
| ColdZyme | Other | The study is intended to verify the method used to measure the duration of ColdZyme®.
Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Receives: Device: ColdZyme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the ColdZyme barrier
To measure the duration of the ColdZyme barrier following intra-oral deposition, by analyzing the oro-pharyngeal glycerol amount over time between 0 and 60 minutes after application.
Measured: 0-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start7 May 2019
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymatica AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bardur Sigurgeirsson, MD, PhD, Principal investigator, Cutis Clinical Research Center (CCRC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901846
- Sponsor's protocol ID
- CI70
- Status last verified
- Oct 2019
- First submitted
- 2 Apr 2019
- Last updated
- 11 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of ColdZyme® II
- ClinicalTrials.gov ID
- NCT03901846
- Acronym / sponsor ID
- CI70
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Enzymatica ABIndustry (pharma, biotech, devices)
- Study start
- 7 May 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 3 Apr 2019 (actual)
- 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.
The objective of this investigation is to verify that ColdZyme® is deposited onto the throat and estimate the half-life of the ColdZyme® solution in the oropharynx of human volunteers using a log-linear mixed-effects model (LMM).
Detailed description
The study is an Open Label, Non-Comparative study intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. Samples will be taken from the oropharyngeal membrane using a cotton swab before application, and 1, 3, 5, 10, 20, and 60 minutes after application. Glycerol will then be extracted from the swabs using water and the concentration of glycerol will be measured.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ColdZyme | Other | Device: ColdZymeThe study is intended to verify the method used to measure the duration of ColdZyme®. Each participant will be his own control as samples are taken before application of ColdZyme and used as an internal control. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male or female subjects between 18-70 years. The investigator judges the definition of healthy by medical history.
- No reported symptoms of sore throat.
- Readiness to comply with trial procedures.
- Females of childbearing potential: should use reliable method of birth control.
- Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature, purpose, consequences and possible risks of the clinical study.
Key exclusion criteria (8 listed)
- Known allergy or hypersensitivity to the components of the investigational product
- History and/or presence of clinically significant condition/disorder (self-reported), which per investigator's judgement could interfere with the results of the study or the safety of the subject.
- Any current cold symptom such as sore throat, sneezing, rhinorrhea, malaise, nasal obstruction or cough.
- Use of products, drugs, or food containing glycerol that may influence the study outcome, or concomitant medication with pharmaceuticals that might cause dry mouth (xerostomia), e.g. but not restricted to, morphine or morphine derivates, diuretics, antidepressants or other drugs with anticholinergic effect.
- Females: Pregnant or breast-feeding
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 |
|---|---|---|
| ColdZymeColdZyme is a Class I medical device (CE-marked) with the following composition: glycerol, water, Tris buffer, CaCl2, menthol and trypsin | Device | ColdZyme |
Primary outcome
Duration of the ColdZyme barrier
Time frame: 0-60 minutes
To measure the duration of the ColdZyme barrier following intra-oral deposition, by analyzing the oro-pharyngeal glycerol amount over time between 0 and 60 minutes after application.
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 11 Oct 2019.
- Individual participant dataSharing planned: No
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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.
Bardur Sigurgeirsson, MD, PhD principal investigator
Cutis Clinical Research Center (CCRC)
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 in people with Common Cold, run by Enzymatica AB at 1 site in Iceland.
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 8 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 11 Oct 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 Iceland. 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. 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?
Duration of the ColdZyme barrier (time frame: 0-60 minutes). 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 11 Oct 2019; AzTrials last refreshed its copy on 29 Oct 2026.