Efficacy
±, AUCAs, sore throat
COLD SYMPTOMS, SECONDARY, SORE THROAT, COMMON COLD
The primary endpoint was defined as the AUC for the WURSS-21 QoL composite sub-score assessed during the first 8 days of common cold symptoms (AUCAs the confirmatory test for the primary efficacy endpoint failed statistical significance, both major secondary endpoints were evaluated exploratory. The first major secondary endpoint was defined as the AUC for the composite daily severity of all symptoms within the Jackson scale assessed during the first 8 days of common cold symptoms (AUCThe second major secondary endpoint was defined as the number of days with concomitant treatment possibly affecting common cold symptoms assessed during the first 4 days for each subject, based on the diary entries. Identification of treatments that could possibly affect common cold symptoms was made independently by an external physician. Most subjects (70.4%) (70.6% in the ColdZyme group and 70.2% in the placebo group) had no days with treatment that might affect common cold symptoms and 14.4% (14.7% in the ColdZyme group and 14.2% in the placebo group) of subjects had only one day. In total, 4.1% (4.1% in both groups) of the subjects used concomitant treatment that might affect common cold symptoms on all four days. The difference between the groups was not statistically significant (p = 0.885).Significant differences or trends for significance in favor of ColdZyme were shown for several exploratory endpoints. The mean number of days with a WURSS-21 QoL score > 0, a measure of illness duration, showed a significant difference between the groups, 6.5 ± 2.7 days (6.0 day median) in the ColdZyme group and 6.9 ± 2.6 days (7.0 day median) in the placebo group (p = 0.050). Likewise, the total number of days of greater than zero on the Jackson symptom score was 6.8 ± 2.6 vs. 7.1 ± 2.6 respectively (p = 0.087) with a median difference of 1.0 day (6.0 vs. 7.0) indicating the median time to recovery was 1 day sooner for the ColdZyme group. These estimates are conservative in that these outcomes require a symptom free or condition free return to baseline. These findings confirm previous observations of shortened common cold duration when using ColdZyme [The beneficial effect of ColdZyme was particularly noticeable on the fifth day of the common cold, often the pivotal day to restoring wellness. The assessment of symptom severity per Jackson score showed 11% less severe symptoms in the ColdZyme group (4.8 ± 5.0) compared to placebo (5.4 ± 4.8, p = 0.066) on this day with a median difference of 1 (score 3.5 vs. 4.5). Further, 10% fewer subjects reported WURSS-21 QoL scores greater than zero in the ColdZyme group (p = 0.031). Moreover, the proportion of subjects reporting to having no common cold on Day 5 was 33.5% for the ColdZyme group vs. 22.0% for the placebo group (p = 0.005).The ColdZyme group showed broadly similar scores to the control group in the remaining secondary endpoints comprising the single items and symptoms of the WURSS-21 and Jackson scales, day with maximum score, use of and exposure during the first 4 days to concomitant treatment, duration of the first intense phase, symptom intensity, sore throat scale and number of days sick at home due to common cold. At study end, subjects assessed the global efficacy of the investigational product on a scale of “very good”, “good”, “moderate” and “poor”. A statistically significant difference between treatment groups was seen as 70.6% of subjects rated the efficacy as “very good” or “good” in the ColdZyme group as opposed to 60.1% in the placebo group (p = 0.001). The investigators’ assessed the efficacy of the investigational product similarly, with ratings “very good” or “good” for 64.3% of the subjects in the ColdZyme group, as opposed to 59.2% in the placebo group (p = 0.045). Similar results regarding efficacy are obtained for the PPS and the FAS.