Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Analyze & Realize | NETWORK |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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 | 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:
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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ColdZyme | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Days 1-8 (day 1 is the first day of symptoms) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Days 1-8 (day 1 is the first day of symptoms) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Physical examination | Physical examination: standard clinical examination of the gastrointestinal tract, cardiovascular system, eyes, respiratory tract, lymph nodes, musculoskeletal system, neurological functions, urogenital tract, thyroid gland and skin. | From enrolment through study completion, maximum 16 weeks |
Inclusion Criteria:
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:
Participation is based upon written informed consent by the participant following written and oral information by the investigator regarding nature,
Exclusion Criteria:
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
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ralf Uebelhack, Prof. Dr. med. | analyze & realize GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| analyze & realize GmbH | Berlin | Germany | ||||
| emovis GmbH |
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.
Beginning 3 months and ending 5 years following article publication.
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. Proposals should be directed to fredrik.lindberg@enzymatica.com. To gain access, data requestors will need to sign a data access agreement.
Not provided
Not provided
| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ColdZyme Placebo | Device | 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. |
|
| 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). |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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" | From enrolment through study completion, maximum 16 weeks |
| Safety endpoint: Vital signs |
Vital signs: blood pressure (mmHg) |
| From enrolment through study completion, maximum 16 weeks |
| Safety endpoint: Vital signs | Vital signs: pulse rate (bpm) | From enrolment through study completion, maximum 16 weeks |
| Safety endpoint: Global evaluation of tolerability by subjects and investigators | Global evaluation of tolerability by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor" | From enrolment through study completion, maximum 16 weeks |
| Safety endpoint: Assessment of adverse events | Assessment of adverse events throughout the study | From enrolment through study completion, maximum 16 weeks |
| Safety endpoint: Assessment of device deficiencies | Assessment of device deficiencies at V2 and V3 | From enrolment through study completion, maximum 16 weeks |
| Berlin |
| Germany |
| Klinische Forschung Berlin-Mitte GmbH | Berlin | Germany |
| Klinische Forschung Berlin | Berlin | Germany |
| Polikum Institut GmbH | Berlin | Germany |
| Praxis Frau Barbara Grube | Berlin | Germany |
| Thomas Wünsche | Berlin | Germany |
| BioTeSys GmbH | Esslingen am Neckar | Germany |
| Praxis Dr. med. Gudrun Ruhland | Koßdorf | Germany |
| SIBAmed Studienzentrum GmbH und Co. KG | Leipzig | Germany |
| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |