Interventions
sore throat, ailment, bacterial infection, Sore, throat, chilliness, cough, headache
SORE THROAT, BACTERIAL INFECTION, COMMON COLD, COLD SYMPTOMS, COLD
All subjects received the subject diary to be used throughout the study. The diary comprised a daily question with regard to a possible onset of common cold symptoms and, after onset, specific questions to record the daily symptoms (Jackson, WURSS-21 QoL, Sore Throat Scale). Those randomized to the ColdZyme group received the investigational device, a throat spray consisting of glycerol, water, trypsin secreted from the pyloric caeca of the Atlantic cod, ethanol (<1%), calcium chloride, trometamol and menthol (ColdZymeFrom the first day of entering the treatment phase the subjects started to record their symptoms twice daily, in the morning and in the evening, on the Jackson scale [The Jackson score was calculated by summing the scores for the following 8 symptoms: sore throat, blocked nose, runny nose, cough and sneezing (local symptoms) as well as headache, malaise, and chilliness (systemic symptoms). Symptoms were assessed on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. The 9 item (items 12 to 20) QoL domain of the WURSS-21 was calculated by summing the individual scores recorded for the question “How much has your cold interfered with your ability to…”: Think clearly, sleep well, breathe easily, walk-climb stairs-exercise, accomplish daily activities, work outside the home, work inside the home, interact with others, and live your personal life [Within 3 days of experiencing the first signs of common cold symptoms, the subjects presented to the investigator for a physical examination and confirmation of the common cold (Visit 2). The third and last visit to the study site for subjects having experienced a common cold had to take place by day 16 (+/-4 days) after symptom start (Visit 3). A maximum of one episode of common cold per subject were registered, before exiting the study. Subjects with no symptoms during the study period (who thus did not use the study treatment) only had a termination visit 16 weeks (+/-7 days) after enrolment.Both groups were allowed to use optional care (as”rescue” treatment) comprising paracetamol (acetaminophen), maximum 2 g/day, ibuprofen, maximum 400 mg/day or saline nose drops or spray, if needed for symptom relief. Antibiotics were allowed if medically required for another ailment following the confirmation of a bacterial infection however, were not to be used for common cold.