Glucose Oxidase as Treatment Against Common Cold

Study Overview
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Brief Summary
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Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey. Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in laboratory studies. In the present study we aim to investigate if a nasal spray with glucose oxidase could treat a common cold, when the treatment is started even after the onset of the symptoms. The study is randomized and placebo controlled.

Detailed Description
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Persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms. Before they start the treatment with the nasal spray they perform a viral sample from the nose and also fill in the WURSS-21 protocol. After this the persons spray with glucose oxidase+glucose/only saline+glucose 5 times the first day and thereafter 3 times daily for a total treatment of one week. Every day the included persons fill in the WURSS-21 protocol.

Official Title
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A Placebo Controlled Study With a Nasal Spray Containing Glucose Oxidase, Aiming to Induce a Faster Recovery From an Episode of Common Cold

Conditions
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Common Cold

Intervention / Treatment
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* Drug: Glucose oxidase + glucose
* Drug: Saline+glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of a common cold within the last 24 hours Exclusion Criteria: Use of a nasal steroid due to allergy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Saline+glucose<br>A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week | Drug: Saline+glucose<br>* Placebo arm<br>|
| Active Comparator: Glucose oxidase + glucose<br>A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week. | Drug: Glucose oxidase + glucose<br>* Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sum of All Symptoms in Viruspositive Persons | Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day. | One week | 
| Sum of All Symptoms of All Persons That Fullfilled the Study | Symptoms of a common cold, recorded in a home protocol, Wisconsin Upper Respiratory Symptom Score 21 (WURSS21) daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as the sum of all symptoms in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Duration