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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
701
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.
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.
analyze & realize GmbH
Berlin, Germany
emovis GmbH
Berlin, Germany
Klinische Forschung Berlin-Mitte GmbH
Berlin, Germany
Klinische Forschung Berlin
Berlin, Germany
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.
Time frame: Days 1-8 (day 1 is the first day of symptoms)
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)
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
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).
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
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)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
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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
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)
AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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"
Time frame: From enrolment through study completion, maximum 16 weeks