Clinical Trial: Evaluation of ColdZyme® on Experimentally Induced Common Cold.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: Enzymatica AB

Current Primary Outcome: Reduction of virus load [ Time Frame: 7 days ]

The primary objective is to investigate the protective effect of ColdZyme® mouth spray against infection in the oropharynx by common cold virus (rhinovirus 16) in vivo in relation to placebo


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Reduce the number of days with common cold symptoms [ Time Frame: 11 days ]
  • Reduce the number of days with virus present in oropharynx [ Time Frame: 11 days ]


Original Secondary Outcome: Same as current

Information By: Enzymatica AB

Dates:
Date Received: June 22, 2015
Date Started: March 2016
Date Completion: December 2016
Last Updated: September 12, 2016
Last Verified: September 2016