Early intervention with a glycerol throat spray containing cold-adapted cod trypsin after self-diagnosis of the common cold: a randomised prospective, parallel group and single-blind methods trial (Glycerol-cod trypsin spray in common cold)

Abstract

Background: A glycerol throat spray containing cold-adapted cod trypsin (GCTS) deactivates common cold virus in vitro and decreases pharyngeal rhinovirus load after inoculation in humans. We relied on early self-diagnosis and evaluated two different scales to detect a treatment effect in naturally occurring common colds. Methods: Adults were enrolled in this randomised, prospective, parallel group, single-blind study to begin treatment six times daily at first sign of a common cold or were assigned to a non-treated group. Jackson′s symptom scale and the 9-item Wisconsin Upper Respiratory Symptom Survey (WURSS)-21 quality of life (QoL) domain were recorded daily by subjects and area under the curve over 12 days (AUC1-12) calculated. Results: Treatment resulted in reduced symptoms with an AUC1-12 of 45.1 ± 32.5 for Jackson scores compared to 53.8 ± 35.7 in the controls (p=0.023). AUC1-12 for the 9-item WURSS-21 QoL domain was likewise improved, 113.6 ± 107.7 and 152.7 ± 126.3 (p=0.006), respectively. During the first four days fewer of the treated subjects (35.3%) used rescue medication than did the control group (50.4%, p=0.014). Conclusions: Reduction in common cold symptoms was seen with treatment with a glycerol throat spray containing cold-adapted cod trypsin. This effect was best detected with the 9-item WURSS-21 QoL domain.

Early intervention with ColdZyme mouth spray after self-diagnosis of common cold: a randomized, double-blind, placebo-controlled study

“…The study found that ColdZyme was able to reduce the duration of the common cold, symptom severity ratings, and the associated number of missed training days. Lastly, the safety and tolerability of ColdZyme shown in previous trials [13][14]19 has now been confirmed in a large study population.…”

“…The common cold started with a similar mean burden of symptoms in the two groups, with a Jackson score of 7.3 ± 3.6 (mean and standard deviation, SD) for the ColdZyme group and 7.1 ± 3.7 for the placebo group on the evening of Day 1, which was similar to the previous single-blind trial (7.5 in the treated group). 14 The common cold was confirmed by a blinded investigator within three days from the start of a perceived common cold at Visit 2 in 98.2% of the subjects in the ColdZyme group and 99.1% in the placebo group, with no statistically significant difference.…”

“…The inclusion and exclusion criteria were identical to the criteria in the previous trial. 14 After enrolment and randomization, the study was conducted in an initial surveillance phase (checking daily for any onset of the common cold symptoms, documented in the diary), followed by a treatment phase initiated once the participants experienced first perception of a common cold. During the conduct of the study the number of subjects to be enrolled was raised from 600 to 701 in order to reach the required number of subjects experiencing common cold symptoms.…”

“…These findings confirm previous observations of shortened common cold duration when using ColdZyme. [13][14]19 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).…”

“…individuals with frequent common colds) to assess whether the study design could adequately evaluate the common cold using symptom scoring with the Jackson scale as well as by quality of life scoring with the 9-item Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life (QoL) sub-score. 14 The preceding study also investigated whether treatment with ColdZyme in addition to optional care, when initiated at the first self-perceived prodromal symptoms could alleviate and shorten a common cold, in comparison to optional care only (“no treatment” group). The 9-item WURSS-21 QoL domain composite score, as well as eight out of nine individual QoL items, were found to be the most sensitive instrument for demonstrating that treatment with ColdZyme compared to “no treatment” significantly improved the common colds sufferers’ quality of life.…”