NCT03794804

Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 701 (actual)
• Sponsor: Enzymatica AB · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a placebo device.

Conditions

• Common Cold

Interventions

Type	Name	Description
DEVICE	ColdZyme	ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (\<1 %), calcium chloride, trometamol and menthol. ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
DEVICE	ColdZyme Placebo	The placebo mouth spray solution has the following composition: ethanol (\<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.

Timeline

• Start date: 2019-01-28
• Primary completion: 2019-06-26
• Completion: 2019-06-26
• First posted: 2019-01-07
• Last updated: 2019-08-22

Locations

10 sites across 1 country: Germany