TITLE:
A Randomized, Double-Blind, Placebo-Controlled Pilot Clinical Study on ColdZyme® Mouth Spray against Rhinovirus-Induced Common Cold
AUTHORS:
Mats Clarsund, Marcus Fornbacke, Lena Uller, Sebastian L. Johnston, Cecilia Ahlström Emanuelsson
KEYWORDS:
Common Cold, Rhinovirus, ColdZyme®® Mouth Spray
JOURNAL NAME:
Open Journal of Respiratory Diseases,
Vol.7 No.4,
October
16,
2017
ABSTRACT: Common colds incur significant costs in terms of sick leave and personal discomfort
for affected individuals. This study investigated the performance of
ColdZyme® Mouth Spray (ColdZyme), a protective barrier against common
cold, in rhinovirus-inoculated healthy volunteers. This randomized, doubleblind,
placebo-controlled pilot study was conducted on 46 healthy volunteers
inoculated with rhinovirus 16 via the nose. Subjects self-administered ColdZyme or placebo 6 times daily for 11 days. Symptoms were recorded daily in a
diary. Rhinovirus 16 in nasal and oropharyngeal samples at days 0, 3, 4, 6, 7
and 10 were quantified by RT-qPCR. The primary outcome measure was the
reduction in viral load in oropharyngeal samples. Rhinovirus 16 was only detected
in 35 out of 46 inoculated subjects. Exploratory analysis measuring the
total viral load (i.e., area under the curve (AUC)) for days 3 - 10 in successfully
inoculated subjects found that ColdZyme treatment resulted in a lower total
viral load in the oropharynx (p = 0.023). In subjects who experienced symptomatic
common cold, irrespectively, if virus were detected, treatment with
ColdZyme resulted in a reduction in the number of days with common cold
symptoms from 6.5 to 3.0 days (p = 0.014) in comparison to placebo. ColdZyme reduced virus infection in the oropharynx and reduced the number of
days with common cold symptoms and highlights the possible importance of
the oropharynx in common cold infections. Suitable outcome measures for a
feasible study on ColdZyme are total viral load in the oropharynx in subjects
having detectable virus present in nasal or oropharyngeal samples.