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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline+glucose nasal spray | Placebo Comparator | 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 |
|
| Nasal spray with glucose oxidase+glucose | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose oxidase+5%glucose | Device | A hydrogen peroxide producing enzyme |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krister Tano, MD,PhD | Umeå University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Försvarshälsan | Boden | Sweden | ||||
| Idrottsmedicin |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Healthy adult volunteers. One part of the included participants was from an education in elite skiing at the University and one part was from a military unit. The participants were told to start the treatment as soon as they were convinced that they had caught a common cold
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Full Range | units on a scale | One week |
|
January 2013 to May 2013
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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Too few virus positive persons in order to get significant results. Local side effects were mild and about the same as in the placebo Group. Influensa season and few rhinovirus infections.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Krister Tano | Umeå University | 0046705569043 | krister.tano@umu.se |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Saline+5%glucose | Device | Isotonic saline + 5% glucose in a bag-on-valve nasal spray device |
|
| Umeå |
| Sweden |
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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 |
| OG001 | 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 |
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| EG001 | 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 | 0 | 50 | 0 | 50 |
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| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |