Common Cold
Conditions
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 description
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.
Interventions
DEVICEGlucose oxidase+5%glucose
A hydrogen peroxide producing enzyme
DEVICESaline+5%glucose
Isotonic saline + 5% glucose in a bag-on-valve nasal spray device
Sponsors
Umeå University
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
Yes
Inclusion criteria
* Healthy adults
Exclusion criteria
* Ongoing allergy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reducing Symptoms of a Common Cold | 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. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Saline+Glucose Nasal Spray A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week
Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device | 48 |
| Nasal Spray With Glucose Oxidase+Glucose A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.
Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme | 50 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | No episode of common cold | 25 | 23 |
Baseline characteristics
| Characteristic | Nasal Spray With Glucose Oxidase+Glucose | Saline+Glucose Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants | 47 Participants | 95 Participants |
| Age, Continuous | 40 years | 38 years | 39 years |
| Region of Enrollment Sweden | 50 participants | 48 participants | 98 participants |
| Sex: Female, Male Female | 28 Participants | 30 Participants | 58 Participants |
| Sex: Female, Male Male | 22 Participants | 18 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 50 |
| serious Total, serious adverse events | 0 / 48 | 0 / 50 |
Outcome results
Primary
Reducing Symptoms of a Common Cold
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.
Time frame: One week
Population: Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Start value | 53 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 1 | 55 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 2 | 55 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 3 | 40 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 4 | 31 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 6 | 14 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 5 | 22 units on a scale |
| Saline+Glucose Nasal Spray | Reducing Symptoms of a Common Cold | Value day 7 | 10 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 5 | 20 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Start value | 53 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 4 | 29 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 1 | 54 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 6 | 14 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 2 | 49 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 7 | 12 units on a scale |
| Nasal Spray With Glucose Oxidase+Glucose | Reducing Symptoms of a Common Cold | Value day 3 | 36 units on a scale |