NCT01883427

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Krister Tano · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Accepted

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.

Conditions

• Upper Respiratory Tract Infections

Interventions

Type	Name	Description
DRUG	Placebo	placebo containing saline+glucose
DRUG	Glucose oxidase	a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.

Timeline

• Start date: 2012-10-01
• Primary completion: 2013-05-01
• Completion: 2013-06-01
• First posted: 2013-06-21
• Last updated: 2016-01-11
• Results posted: 2016-01-11

Locations

4 sites across 1 country: Sweden