Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children

Phase 2

Completed

• Conditions: Upper Respiratory Tract Infections
• Interventions: Drug: Placebo; Drug: Glucose oxidase

• Registration Number: NCT01883427
• Lead Sponsor: Krister Tano

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-04-23
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Study First Submitted QC: 2013-06-20
• Study First Posted: 2013-06-21
• Results First Submitted: 2015-04-16
• Status Verified: 2015-12
• Results First Submitted QC: 2015-12-07
• Last Update Submitted: 2015-12-07
• Results First Posted: 2016-01-11
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children below 4 years of age

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo: Saline+glucose nasal spray	Placebo	Subjects received nasal spray containing both saline+glucose twice daily for 3 months
Nasal spray with glucose oxidase+glucose	Glucose oxidase	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Öronmottagningen; 🇸🇪 Östersund, Sweden