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

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.

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Key information

Conditions

Common Cold Infections Picornaviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Försvarshälsan, Boden, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy adults

Exclusion criteria

Ongoing allergy

Treatment and study plan

Glucose oxidase+5%glucose

Device

A hydrogen peroxide producing enzyme

Saline+5%glucose

Device

Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Registry information

Official study 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

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jun 21, 2013
Registry last updated: Nov 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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