Back to resultsGlucose Oxidase as Treatment Against Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Glucose oxidase + glucose
Saline+glucose
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold focused on measuring Duration
Eligibility Criteria
Inclusion Criteria:
- Symptoms of a common cold within the last 24 hours
Exclusion Criteria:
- Use of a nasal steroid due to allergy
Sites / Locations
- Öronmottagningen
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Saline+glucose
Glucose oxidase + glucose
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01883440
Brief Title
Glucose Oxidase as Treatment Against Common Cold
Official Title
A Placebo Controlled Study With a Nasal Spray Containing Glucose Oxidase, Aiming to Induce a Faster Recovery From an Episode of Common Cold
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Krister Tano
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
Keywords
Duration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline+glucose
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Glucose oxidase + glucose
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Glucose oxidase + glucose
Intervention Description
Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
Intervention Type
Drug
Intervention Name(s)
Saline+glucose
Intervention Description
Placebo arm
Primary Outcome Measure Information:
Title
Sum of All Symptoms in Viruspositive Persons
Description
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.
Time Frame
One week
Title
Sum of All Symptoms of All Persons That Fullfilled the Study
Description
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.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Symptoms of a common cold within the last 24 hours
Exclusion Criteria:
Use of a nasal steroid due to allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helena Toolanen, MD
Organizational Affiliation
Norrbottens Läns Landsting
Official's Role
Study Chair
Facility Information:
Facility Name
Öronmottagningen
City
Sunderbyn
Country
Sweden
12. IPD Sharing Statement
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Glucose Oxidase as Treatment Against Common Cold
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