Upper Respiratory Tract Infections
Conditions
Keywords
Days with URTI symptoms
Brief summary
To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.
Detailed description
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.
Interventions
DRUGPlacebo
placebo containing saline+glucose
DRUGGlucose oxidase
a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
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
No minimum to 3 Years
Healthy volunteers
Yes
Inclusion criteria
* Children below 4 years of age
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Infectious Symptoms | 3 months of recording | Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children. |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Nasal Spray With Glucose Oxidase+Glucose | Saline+Glucose Nasal Spray | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 20 Participants | 40 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 27 months | 28 months | 28 months |
| Region of Enrollment Sweden | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Male | 11 Participants | 12 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
Time frame: 3 months of recording
Population: Only a total of 40 Children fulfilled the study, which means that the Power are to low.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saline+Glucose Nasal Spray | Respiratory Infectious Symptoms | Days with URTI | 9 days | Standard Deviation 4 |
| Saline+Glucose Nasal Spray | Respiratory Infectious Symptoms | Days with rhinitis | 10 days | Standard Deviation 6 |
| Saline+Glucose Nasal Spray | Respiratory Infectious Symptoms | Days with cough and rhinitis | 6 days | Standard Deviation 5 |
| Saline+Glucose Nasal Spray | Respiratory Infectious Symptoms | days with fever | 3 days | Standard Deviation 3 |
| Nasal Spray With Glucose Oxidase+Glucose | Respiratory Infectious Symptoms | days with fever | 5 days | Standard Deviation 4 |
| Nasal Spray With Glucose Oxidase+Glucose | Respiratory Infectious Symptoms | Days with URTI | 13 days | Standard Deviation 10 |
| Nasal Spray With Glucose Oxidase+Glucose | Respiratory Infectious Symptoms | Days with cough and rhinitis | 8 days | Standard Deviation 6 |
| Nasal Spray With Glucose Oxidase+Glucose | Respiratory Infectious Symptoms | Days with rhinitis | 13 days | Standard Deviation 10 |
Comparison: Too few included to reach powerp-value: >0.05Wilcoxon (Mann-Whitney)