Common ColdNCT03794804
Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
A study testing ColdZyme in people with Common Cold, run by Enzymatica AB at 10 sites in Germany.
Trial summary
This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device. 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?
- Yes, some participants may receive a placebo
- How many people
- 701 participants
- Where
- 10 sitesGermany
- Study dates
- 28 Jan 2019to 26 Jun 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
- 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, including in particular:
- Use of IP as recommended
- Filling in diary
Show all 12Show fewer
- Keeping habitual life-style, including diet and physical activity level
- No use of products that may influence the study outcome (e.g. immune suppressants/immune stimulants including natural health products, analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) during the study (except for the defined "rescue" treatment)
- 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,
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
- Asthma, chronic obstructive lung disease or any other acute/chronic airways disease/disorder (e.g. chronic cough of any origin)
- Acute psychiatric disorders
- Any other acute/chronic serious organ or systemic diseases
Show all 13Show fewer
- 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/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1
- 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
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
analyze & realize GmbH
Berlin
emovis GmbH
Berlin
Klinische Forschung Berlin-Mitte GmbH
Berlin
Klinische Forschung Berlin
Berlin
Polikum Institut GmbH
Berlin
Praxis Frau Barbara Grube
Berlin
Thomas Wünsche
Berlin
BioTeSys GmbH
Esslingen am Neckar
Praxis Dr. med. Gudrun Ruhland
Koßdorf
SIBAmed Studienzentrum GmbH und Co. KG
Leipzig
About this study
This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.
- Conditions
- Common Cold
- Being tested
- ColdZyme, ColdZyme 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.
ColdZymeDevice
ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
ColdZyme PlaceboDevice
The placebo mouth spray solution has the following composition: ethanol (<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
| Study group | Role | What they receive |
|---|---|---|
| ColdZyme | Active comparator | ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.
The IP use should start when following conditions have been fulfilled:
* Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND
* A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache
The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total. Receives: Device: ColdZyme |
| Placebo | Placebo comparator | Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.
The IP use should start when following conditions have been fulfilled:
* Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND
* A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache
The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total. Receives: Device: ColdZyme Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
WURSS-21 QoL sub score
The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.
Measured: Days 1-8 (day 1 is the first day of symptoms)
Secondary outcomes (11)
1. Composite daily severity of all symptoms within the Jackson score
The first major secondary endpoint: AUC days 1-8 composite daily severity of all symptoms within the Jackson score (mean of morning and evening) (day 1 is the first day of symptom recording)
Measured: Days 1-8 (day 1 is the first day of symptoms)
2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms
The second major secondary endpoint: Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/ anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose, expressed as number of days with concomitant treatment during the first 4 days for each subject (based on diary data).
Measured: Days 1-4 (day 1 is the first day of symptoms)
Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item
AUC days 1-8 for each single WURSS-21 QoL subscore item
Measured: Days 1-8 (day 1 is the first day of symptoms)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
Measured: Days 1-8 (day 1 is the first day of symptoms)
AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
Measured: Days 1-8 (day 1 is the first day of symptoms)
Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose
Frequency of subjects with use of concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose
Measured: Days 1-4
Assessment of duration of first intense phase
Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring <5 in total Jackson score
Measured: From enrolment through study completion, maximum 16 weeks
Assessment of symptom intensity
Assessment of symptom intensity, expressed as mean total Jackson score days 1-4
Measured: Days 1-4
Assessment of symptom sore throat per Sore Throat Scale
Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8
Measured: Days 1-8
Percentage of subjects with confirmed common cold at Visit 2
Percentage of subjects with confirmed common cold at Visit 2 (from all subjects with V2), which should take place within 1-3 days after symptom start
Measured: 1-3 days after symptom start
Global evaluation of efficacy by subjects and investigators at study end
Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"
Measured: From enrolment through study completion, maximum 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start28 Jan 2019
- Primary completion26 Jun 2019
- Study completion26 Jun 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 701 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. Dr. med., Principal investigator, analyze & realize GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03794804
- Sponsor's protocol ID
- 008618
- Status last verified
- Aug 2019
- First submitted
- 3 Jan 2019
- Last updated
- 22 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 the approved proposal.
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold
- ClinicalTrials.gov ID
- NCT03794804
- Acronym / sponsor ID
- 008618
- Conditions
- Common Cold
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 701 participants (actual)
- Lead sponsor
- Enzymatica ABIndustry (pharma, biotech, devices)
- Collaborators
- Analyze & Realize
- Study start
- 28 Jan 2019 (actual)
- Primary completion
- 26 Jun 2019 (actual)
- Study completion
- 26 Jun 2019 (actual)
- First posted
- 7 Jan 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 impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.
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: ColdZymeColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: * Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND * A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total. |
| Placebo | Placebo comparator | Device: ColdZyme PlaceboWater based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion. The IP use should start when following conditions have been fulfilled: * Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND * A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 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, including in particular:
- 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/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray) within the last 4 weeks prior to V1
- 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, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol. ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap. | Device | ColdZyme |
| ColdZyme PlaceboThe placebo mouth spray solution has the following composition: ethanol (<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap. | Device | Placebo |
Primary outcome
WURSS-21 QoL sub score
Time frame: Days 1-8 (day 1 is the first day of symptoms)
The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.
11 secondary outcomes
1. Composite daily severity of all symptoms within the Jackson score
Time frame: Days 1-8 (day 1 is the first day of symptoms)
2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms
Time frame: Days 1-4 (day 1 is the first day of symptoms)
Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item
Time frame: Days 1-8 (day 1 is the first day of symptoms)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)
Time frame: Days 1-8 (day 1 is the first day of symptoms)
AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)
Time frame: Days 1-8 (day 1 is the first day of symptoms)
Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose
Time frame: Days 1-4
Assessment of duration of first intense phase
Time frame: From enrolment through study completion, maximum 16 weeks
Assessment of symptom intensity
Time frame: Days 1-4
Assessment of symptom sore throat per Sore Throat Scale
Time frame: Days 1-8
Percentage of subjects with confirmed common cold at Visit 2
Time frame: 1-3 days after symptom start
Global evaluation of efficacy by subjects and investigators at study end
Time frame: From enrolment through study completion, maximum 16 weeks
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 22 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 the approved proposal.
Related trials for Common Cold
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
Recruiting
Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction
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. Dr. med. principal investigator
analyze & realize GmbH
10 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 10 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 12 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 22 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 10 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. 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?
WURSS-21 QoL sub score (time frame: Days 1-8 (day 1 is the first day of symptoms)). 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 22 Aug 2019.