Title
Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
Placebo Controlled Study Among Children Below Four Years of Age, Investigating Whether a Glucose Oxidase Nasal Spray Can Reduce Days With Upper Respiratory Tract Infection Symptoms
Phase
Phase 2Lead Sponsor
Umeå UniversityStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Upper Respiratory Tract InfectionsIntervention/Treatment
glucose oxidase ...Study Participants
40To 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.
placebo containing saline+glucose
a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
Subjects received nasal spray containing both saline+glucose twice daily for 3 months
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.
Inclusion Criteria: Children below 4 years of age Exclusion Criteria: None
| Event Type | Organ System | Event Term | Saline+Glucose Nasal Spray | Nasal Spray With Glucose Oxidase+Glucose |
|---|
Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.
