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To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.
Children below 4 years of age and in public day care were invited to participate in this prospective study. The children started with a visit to an ENT doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. During this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. After 6 weeks and 12 weeks the children had scheduled visits to the ENT department, where an ENT doctor examined the throat, nasal cavity and the ear drums for otitis media. After 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo: Saline+glucose nasal spray | Placebo Comparator | Subjects received nasal spray containing both saline+glucose twice daily for 3 months |
|
| Nasal spray with glucose oxidase+glucose | Active Comparator | Nasal spray in a bag-on-valve device with 50U/ml containing both glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | placebo containing saline+glucose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Respiratory Infectious Symptoms | Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children. | 3 months of recording |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Westman, MD, PhD | Västernorrlands Landsting | Study Chair |
| Marie Ryding, MD, PhD | Jämtlands Landsting | Study Chair |
| Anders Niklasson, MD | Norrbottens Landsting | Study Chair |
| Helena Toolanen, MD | Norrbottens Landsting | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Öronmottagningen | Östersund | Sweden | ||||
| Öronmottagningen |
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| ID | Title | Description |
|---|---|---|
| FG000 | Saline+Glucose Nasal Spray | Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose |
| FG001 | Nasal Spray With Glucose Oxidase+Glucose | Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Pre-school children
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| ID | Title | Description |
|---|---|---|
| BG000 | Saline+Glucose Nasal Spray | Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose |
| BG001 | Nasal Spray With Glucose Oxidase+Glucose |
| 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 | Respiratory Infectious Symptoms | Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children. | Only a total of 40 Children fulfilled the study, which means that the Power are to low. | Posted | Mean | Standard Deviation | days | 3 months of recording |
|
During the study period of 3 months
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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 | Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| local side effects | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Local side effects in the nasal cavity |
We wanted 200 Children but only 40 fulfilled the study, which make the results hard to evaluate.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| MD, PhD Krister Tano | Umeå University | 0046705569043 | krister.tano@umu.se |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D005949 | Glucose Oxidase |
| ID | Term |
|---|---|
| D000429 | Alcohol Oxidoreductases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| Glucose oxidase | Drug | a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive. |
|
|
| Piteå |
| Sweden |
| Öronmottagningen | Södra Sunderbyn | Sweden |
| Öronmottagningen | Sundsvall | Sweden |
Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.
Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Nasal Spray With Glucose Oxidase+Glucose | Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx | 0 | 20 | 0 | 20 |
|
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