NCT02479750

Evaluation of ColdZyme® on Experimentally Induced Common Cold.

Evaluation of ColdZyme® on Experimentally Induced Common Cold. -A Double-blind, Randomized, Placebo-controlled Study in Healthy Volunteers.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Enzymatica AB · Industry
• Sex: All
• Age: 16 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the performance of ColdZyme® mouth spray on prevention of common cold symptoms on experimentally induced rhinovirus upper respiratory tract infection in healthy volunteers. Half of participants will receive ColdZyme® mouth spray while the other half will receive placebo.

Detailed description

88 subjects will be inoculated with rhinovirus 16 via the nasal route. The subjects will be randomized 1:1 to ColdZyme® or placebo. Treatment (6 doses per day) will be applied for 11 days from the day of inoculation. The subjects will visit the investigational clinic on 6 occasions. During these visits the subjects will leave nasal (lavage) and pharyngeal (swab) samples for quantification of virus replication. All subjects will have a diary for scoring of cold symptoms.

Conditions

• Common Cold

Interventions

Type	Name	Description
DEVICE	ColdZyme® mouth spray
DEVICE	Placebo

Timeline

• Start date: 2016-03-23
• Primary completion: 2016-07-25
• Completion: 2016-07-25
• First posted: 2015-06-24
• Last updated: 2019-02-07

Locations

1 site across 1 country: United Kingdom