Evaluation of the Use of Various Assessments of Common Cold Symptoms for Proof of Efficacy of ColdZyme Mouth Spray

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Common Cold

Intervention / Treatment
-----------------
* Device: ColdZyme


Participation Criteria
=================
Eligibility Criteria
-----------------
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: Use of IP as recommended (verum group) Filling in diary 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. 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 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 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

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ColdZyme<br> | Device: ColdZyme<br>* 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.<br>|
| No Intervention: Optional care only<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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. | 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. | 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. | 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. | 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. | 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. | From randomisation through study completion, maximum 16 weeks | 
| Number of subjects with adverse events | Any AE that occurs during the course of the study. | From randomisation through study completion, maximum 16 weeks | 
| Number of device deficiencies | Device deficiencies occurring in the active group (verum) | During IP use, maximum 12 days from symptom start |