Common ColdNCT03831763
Evaluation of the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of ColdZyme Mouth Spray
A study testing ColdZyme in people with Common Cold, run by Enzymatica AB at 7 sites in Germany.
Trial summary
This study evaluates the use of various assessments of common cold symptoms for proof of efficacy of ColdZyme Mouth Spray on naturally acquired common colds. Half of the participants will receive ColdZyme® Mouth Spray while the other half may use optional care as needed. 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
- 400 participants
- Where
- 7 sitesGermany
- Study dates
- 25 Jan 2018to 5 Jun 2018
- 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
- Men and women
- Age 18 to 70 years old
- Increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to V1) but generally in good health
- Readiness to comply with trial procedures:
- Use of IP as recommended (verum group)
- Filling in diary
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- Keeping habitual diet and physical activity level
- Women of child-bearing potential:
- Have to agree to use appropriate contraception methods
- Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at V1
- 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, e.g.:
- Nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or reconstructive surgery
- Acute/chronic airways disease/disorder (e.g. chronic obstructive lung disease, asthma, chronic cough of any origin)
- Acute psychiatric disorders
- Any other acute/chronic serious organ or systemic diseases
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- Influenza vaccination within the last 3 months prior to V1 and during the study
- Regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/antirheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1 and during the study (except for the defined optional care)
- Pregnancy or nursing
- History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or medication
- Participation in the present study of a person living in the same household as the subject
- Inability to comply with study requirements according to investigator's judgement
- Participation in another clinical study in the 30 days prior to V1 and during the study
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
analyze & realize GmbH
Berlin
Barbara Grube
Berlin
Dr. med. Petra Sandow and Eugenia Fischkina
Berlin
Dr. med. Ruhland
Berlin
Klinische Forschung Berlin
Berlin
POLIKUM Institut GmbH
Berlin
Thomas Wünsche
Berlin
About this study
Official title: Single (Investigator)-Blind, Randomized, Parallel-group Study to Evaluate the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of CMS016317
This study evaluates the use of various assessments of common cold symptoms for proof of efficacy of ColdZyme Mouth Spray on naturally acquired common colds. Half of the participants will receive ColdZyme® Mouth Spray while the other half may use optional care as needed.
- 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® Mouth Spray is a CE-marked medical device with the following composition: glycerol, water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
ColdZyme® Mouth Spray consists of a 20 ml bottle, pump, spray nozzle and protective cap.
| Study group | Role | What they receive |
|---|---|---|
| ColdZyme | Active comparator | Not described Receives: Device: ColdZyme |
| Optional care only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the Jackson scale between the study groups
Jackson scale - total score, local symptoms, systemic symptoms, 2-item score (sore throat \& malaise) as recorded in subject diary twice daily, morning and evening). The Jackson score is calculated by summing the following 8 symptom scores: sore throat, blocked nose, runny nose, cough and sneezing (local symptoms) as well as headache, malaise, and chilliness (systemic symptoms). Symptoms are assessed on a 4-point scale: 0 = none (symptom not present), 1 = mild (sensible, but not disturbing or irritating), 2 = moderate (symptoms sometimes disturbing/irritating), 3 = severe (symptoms disturbing/ irritating most of the time).
Measured: 16+/-4 days from start of common cold symptoms
Difference in WURSS-21 Quality of Life sub score between the study groups
WURSS-21 Quality of Life (QoL) recorded in subject diary once daily, in the evening. WURSS-21 is an evaluative illness-specific quality of life instrument with 21 items, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). In this study, the QoL part of the WURSS-21 will be applied, from item 12 ("think clearly") to item 20 ("live your personal life").
Measured: 16+/-4 days from start of common cold symptoms
Difference in the Sore Throat Scale between the study groups
The Sore Throat Scale is a 0-10 Likert scale where 0=not sore and 10=very sore. Recorded in subject diary twice daily, morning and evening.
Measured: 16+/-4 days from start of common cold symptoms
Difference in the Irritated Throat Scale between the study groups
Irritated Throat Scale is a 0-10 Likert scale where 0=not irritated and 10=very irritated. Recorded in subject diary twice daily, morning and evening.
Measured: 16+/-4 days from start of common cold symptoms
Percentage of subjects with prevention of cold outburst
Based on the assessment of the symptoms recorded in the diary by means of the specified criteria for a common cold episode, as well as the evaluation of any symptoms by the investigator at V2 (whether they are attributable to common cold), the percentage of subjects with prevention of common cold outburst (upon originally having experienced initial symptoms) will be assessed.
Measured: Within 3 days from symptom start
Difference in number of findings during physical examination compared between the study groups
Physical examination will be performed using standard products and procedures at all study visits. Physical examination by standard clinical examination of the gastrointestinal tract, cardiovascular system, eyes, respiratory tract, lymph nodes, musculoskeletal system, neurological functions, urogenital tract, thyroid gland and skin.
Measured: From randomisation through study completion, maximum 16 weeks
Blood pressure (mmHg) compared between the study groups
Sitting blood pressure (mmHg), systolic and diastolic, will be measured using standard products and procedures at all study visits.
Measured: From randomisation through study completion, maximum 16 weeks
Pulse rate (bpm) compared between the study groups
Pulse rate (bpm) will be measured using standard products and procedures at all study visits.
Measured: From randomisation through study completion, maximum 16 weeks
Number of subjects with adverse events
Any AE that occurs during the course of the study.
Measured: From randomisation through study completion, maximum 16 weeks
Number of device deficiencies
Device deficiencies occurring in the active group (verum)
Measured: During IP use, maximum 12 days from symptom start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2019
- Study start25 Jan 2018
- Primary completion5 Jun 2018
- Study completion5 Jun 2018
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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzymatica AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Responsible party
- Sponsor
- Investigators
- Ralf Uebelhack, Prof. MD, Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03831763
- Sponsor's protocol ID
- 016317
- Status last verified
- Aug 2019
- First submitted
- 21 Jan 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in hte approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single (Investigator)-Blind, Randomized, Parallel-group Study to Evaluate the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of CMS016317
- ClinicalTrials.gov ID
- NCT03831763
- Acronym / sponsor ID
- 016317
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Enzymatica ABIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 5 Jun 2018 (actual)
- First posted
- 6 Feb 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.
This study evaluates the use of various assessments of common cold symptoms for proof of efficacy of ColdZyme Mouth Spray on naturally acquired common colds. Half of the participants will receive ColdZyme® Mouth Spray while the other half may use optional care as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ColdZyme | Active comparator | Device: ColdZyme |
| Optional care only | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Men and women
- Age 18 to 70 years old
- Increased risk for common cold (at least 3 self-reported occurences of common cold within the last 12 months prior to V1) but generally in good health
- Readiness to comply with trial procedures:
- Women of child-bearing potential:
Key exclusion criteria (13 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, e.g.:
- Influenza vaccination within the last 3 months prior to V1 and during the study
- Regular use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/antirheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1 and during the study (except for the defined optional care)
- Pregnancy or nursing
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® Mouth Spray is a CE-marked medical device with the following composition: glycerol, water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol. ColdZyme® Mouth Spray consists of a 20 ml bottle, pump, spray nozzle and protective cap. | Device | ColdZyme |
Primary outcome
Difference in the Jackson scale between the study groups
Time frame: 16+/-4 days from start of common cold symptoms
Jackson scale - total score, local symptoms, systemic symptoms, 2-item score (sore throat \& malaise) as recorded in subject diary twice daily, morning and evening). The Jackson score is calculated by summing the following 8 symptom scores: sore throat, blocked nose, runny nose, cough and sneezing (local symptoms) as well as headache, malaise, and chilliness (systemic symptoms). Symptoms are assessed on a 4-point scale: 0 = none (symptom not present), 1 = mild (sensible, but not disturbing or irritating), 2 = moderate (symptoms sometimes disturbing/irritating), 3 = severe (symptoms disturbing/ irritating most of the time).
Difference in WURSS-21 Quality of Life sub score between the study groups
Time frame: 16+/-4 days from start of common cold symptoms
WURSS-21 Quality of Life (QoL) recorded in subject diary once daily, in the evening. WURSS-21 is an evaluative illness-specific quality of life instrument with 21 items, designed to assess the negative impact of acute upper respiratory infection, presumed viral (the common cold). In this study, the QoL part of the WURSS-21 will be applied, from item 12 ("think clearly") to item 20 ("live your personal life").
Difference in the Sore Throat Scale between the study groups
Time frame: 16+/-4 days from start of common cold symptoms
The Sore Throat Scale is a 0-10 Likert scale where 0=not sore and 10=very sore. Recorded in subject diary twice daily, morning and evening.
Difference in the Irritated Throat Scale between the study groups
Time frame: 16+/-4 days from start of common cold symptoms
Irritated Throat Scale is a 0-10 Likert scale where 0=not irritated and 10=very irritated. Recorded in subject diary twice daily, morning and evening.
Percentage of subjects with prevention of cold outburst
Time frame: Within 3 days from symptom start
Based on the assessment of the symptoms recorded in the diary by means of the specified criteria for a common cold episode, as well as the evaluation of any symptoms by the investigator at V2 (whether they are attributable to common cold), the percentage of subjects with prevention of common cold outburst (upon originally having experienced initial symptoms) will be assessed.
Difference in number of findings during physical examination compared between the study groups
Time frame: From randomisation through study completion, maximum 16 weeks
Physical examination will be performed using standard products and procedures at all study visits. Physical examination by standard clinical examination of the gastrointestinal tract, cardiovascular system, eyes, respiratory tract, lymph nodes, musculoskeletal system, neurological functions, urogenital tract, thyroid gland and skin.
Blood pressure (mmHg) compared between the study groups
Time frame: From randomisation through study completion, maximum 16 weeks
Sitting blood pressure (mmHg), systolic and diastolic, will be measured using standard products and procedures at all study visits.
Pulse rate (bpm) compared between the study groups
Time frame: From randomisation through study completion, maximum 16 weeks
Pulse rate (bpm) will be measured using standard products and procedures at all study visits.
Number of subjects with adverse events
Time frame: From randomisation through study completion, maximum 16 weeks
Any AE that occurs during the course of the study.
Number of device deficiencies
Time frame: During IP use, maximum 12 days from symptom start
Device deficiencies occurring in the active group (verum)
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 21 Aug 2019.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in hte approved proposal.
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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.
Ralf Uebelhack, Prof. MD principal investigator
analyze & realize GmbH
7 sites 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 7 sites in Germany.
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 11 inclusion and 13 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 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. 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?
Difference in the Jackson scale between the study groups (time frame: 16+/-4 days from start of common cold symptoms). The study lists 10 primary outcomes in all. 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 21 Aug 2019.