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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
400
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.
analyze & realize GmbH
Berlin, Germany
Barbara Grube
Berlin, Germany
Dr. med. Petra Sandow and Eugenia Fischkina
Berlin, Germany
Dr. med. Ruhland
Berlin, Germany
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).
Time frame: 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").
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Klinische Forschung Berlin
Berlin, Germany
POLIKUM Institut GmbH
Berlin, Germany
Thomas Wünsche
Berlin, Germany
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomisation through study completion, maximum 16 weeks
Number of subjects with adverse events
Any AE that occurs during the course of the study.
Time frame: From randomisation through study completion, maximum 16 weeks
Number of device deficiencies
Device deficiencies occurring in the active group (verum)
Time frame: During IP use, maximum 12 days from symptom start