Outcomes
sore throat, throat
SORE THROAT, ADVERSE EVENTS, COMMON COLD, SECONDARY, COLD SYMPTOMS
The aim of the study was to evaluate the efficacy of ColdZyme for common cold, with the study hypothesis that treatment with ColdZyme is superior to placebo in the treatment of naturally occurring common cold. Thereby, the primary objective was to evaluate the impact on quality of life during a common cold episode, based on the primary endpoint defined as the AUC of WURSS-21 QoL composite sub-score for 8 days following start of symptoms (day 1 is the first day of symptom recording).Secondary outcome parameters included two hierarchically ordered major secondary endpoints (1 is highest ranking):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)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).Other secondary endpoints included, among others, single items of the WURSS-21 and single symptoms of the Jackson scale and their duration, day with maximum score, use of and exposure to concomitant treatment during the first 4 days, duration of the first intense phase (defined as number of days from start of treatment until Jackson score < 5, for subjects with a score ≥ 5 during the common cold episode), symptom intensity, a sore throat scale and number of days sick at home due to common cold. In addition, several safety endpoints were defined, including physical examination, vital signs and adverse events throughout the study, as well as global evaluation of tolerability by subjects and investigators at study end and assessment of device deficiencies at Visit 2 and Visit 3.