Common Cold
Conditions
Keywords
Duration
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.
Interventions
DRUGGlucose oxidase + glucose
Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
DRUGSaline+glucose
Placebo arm
Sponsors
Krister Tano
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Symptoms of a common cold within the last 24 hours
Exclusion criteria
* Use of a nasal steroid due to allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sum of All Symptoms in Viruspositive Persons | One week | 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 | 7 days | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline+Glucose 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
saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device | 42 |
| Glucose Oxidase + Glucose 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.
Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device | 45 |
| Total | 87 |
Baseline characteristics
| Characteristic | Glucose Oxidase + Glucose | Saline+Glucose | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants | 42 Participants | 87 Participants |
| Age, Continuous | 41 years | 44 years | 42 years |
| Region of Enrollment Sweden | 45 participants | 42 participants | 87 participants |
| Sex: Female, Male Female | 35 Participants | 33 Participants | 68 Participants |
| Sex: Female, Male Male | 10 Participants | 9 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 45 | 0 / 45 |
| serious Total, serious adverse events | 0 / 45 | 0 / 45 |
Outcome results
Primary
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.
Time frame: One week
Population: The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 6 | 36 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 1 | 54 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 7 | 29 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 2 | 58 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 3 | 52.5 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 4 | 48 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 5 | 39 units on a scale |
| Saline+Glucose | Sum of All Symptoms in Viruspositive Persons | Start value | 52 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 3 | 38 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 2 | 53 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 4 | 31 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 6 | 18 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 5 | 26 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 7 | 14 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Start value | 52 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms in Viruspositive Persons | Value day 1 | 56 units on a scale |
p-value: <0.037Mixed Models Analysis
Primary
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.
Time frame: 7 days
Population: All of the persons that fullfilled the study
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 1 | 44 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 4 | 33 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 6 | 21 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 5 | 27 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 2 | 45 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 3 | 40 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 7 | 17 units on a scale |
| Saline+Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Start | 42 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 7 | 19 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Start | 42 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 2 | 39 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 1 | 42 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 3 | 34 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 4 | 31 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 5 | 27 units on a scale |
| Glucose Oxidase + Glucose | Sum of All Symptoms of All Persons That Fullfilled the Study | Day 6 | 23 units on a scale |
Comparison: In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.p-value: 0.381Mixed Models Analysis