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

NCT ID: NCT01883427

Last Updated: 2016-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-06-30

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.

Conditions

Upper Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo: Saline+glucose nasal spray

Subjects received nasal spray containing both saline+glucose twice daily for 3 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo containing saline+glucose

Nasal spray with glucose oxidase+glucose

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.

Group Type: ACTIVE_COMPARATOR

Glucose oxidase

Intervention Type: DRUG

a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.

Interventions

Placebo

placebo containing saline+glucose

Intervention Type: DRUG

Glucose oxidase

a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.

Intervention Type: DRUG

Other Intervention Names

Baxter Rehydrex; G2133, Sigmaaldrich

Eligibility Criteria

Inclusion Criteria

• Children below 4 years of age

Exclusion Criteria

• None

• Maximum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Krister Tano

OTHER

Sponsor Role: lead

Responsible Party

Krister Tano

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Eva Westman, MD, PhD

Role: STUDY_CHAIR

Västernorrlands Landsting

Marie Ryding, MD, PhD

Role: STUDY_CHAIR

Jämtlands Landsting

Anders Niklasson, MD

Role: STUDY_CHAIR

Norrbottens Landsting

Helena Toolanen, MD

Role: STUDY_CHAIR

Norrbottens Landsting

Locations

Öronmottagningen

Östersund, , Sweden

Öronmottagningen

Piteå, , Sweden

Öronmottagningen

Södra Sunderbyn, , Sweden

Öronmottagningen

Sundsvall, , Sweden

Countries

Sweden

Other Identifiers

GObarn2013

Identifier Type: -

Identifier Source: org_study_id