Clinical Trial: A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Double Blinded Clinical Study Aiming to Shorten an Episode of Common Cold When the Treatment is Started at the Onset of an Episode of Common Cold

Brief Summary: Healthy persons are invited to participate in the study and are given a home protocol (WURSS21), nasal spray and a sample pin. The included persons are told to make a nasopharyngeal sampling from the nose when they are sure that they have caught a common cold. After the sampling they start to spray and also fill in the records daily. The aim of the study is to investigate whether a nasal spray with glucose oxidase could shorten an episode of common cold.

Detailed Summary:

Persons working in a military unit in Boden and persons connected to the Department of Sports Medicine in Umeå were invited to participate in this study. Only persons older than 18 years was included in the study. The persons included received one bottle of study medicine, a home protocol (WURSS 21) and a viral sampling kit. Whenever the included persons were sure that they had received an episode of common cold they were told to perform a viral sampling from the nose, fill in the protocol and start to use the nasal spray several times daily for one week. The treatment was either a) a saline solution with 5% glucose or b) a saline solution with 200U/ml of glucose oxidase and 5%glucose (active treatment group). The combination of glucose oxidase and glucose produces an acid environment, imitating the effect of the normal nasal flora and Human Rhinoviruses are sensitive to an acid environment. After one week of treatment and daily records of the WURSS 21 protocol the persons returned the spray bottles (Bag-on-Valve), the virus vials and the protocols.

A total of 146 persons were included in the study and 98 persons returned protocols.


Sponsor: Umeå University

Current Primary Outcome: Reducing Symptoms of a Common Cold [ Time Frame: One week ]

Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common Cold.

WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups.



Original Primary Outcome: Reduced symptoms of a common cold [ Time Frame: 20130101 - 20130430 ]

Wisconsin Upper Respiratory Symptom Score (WURSS-21)is a validated protocol for assessing symptoms of a common cold. We are using this protocol at start, before the persons in the study start their treatment and thereafter every day for the next 7 days, while they use the nasal spray(glucose oxidase+saline and glucose or only saline+glucose). The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol.


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Umeå University

Dates:
Date Received: April 23, 2013
Date Started: January 2013
Date Completion:
Last Updated: October 9, 2015
Last Verified: June 2015