Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

Study Overview
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Brief Summary
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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.

Official Title
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Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

Conditions
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Common Cold

Intervention / Treatment
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* Device: ColdZyme
* Device: ColdZyme Placebo


Participation Criteria
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Eligibility Criteria
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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: Use of IP as recommended Filling in diary 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, 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.: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ColdZyme<br>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. | Device: ColdZyme<br>* 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.<br>|
| Placebo Comparator: Placebo<br>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. | Device: ColdZyme Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 |