Back to results

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

Primary Purpose

Upper Respiratory Tract Infections

Status

Completed

Phase

Phase 2

Locations

Sweden

Study Type

Interventional

Intervention

Placebo

Glucose oxidase

About this trial

This is an interventional treatment trial for Upper Respiratory Tract Infections focused on measuring Days with URTI symptoms

Eligibility Criteria

undefined - 3 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Children below 4 years of age

Exclusion Criteria:

None

Sites / Locations

Öronmottagningen
Öronmottagningen
Öronmottagningen
Öronmottagningen

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo: Saline+glucose nasal spray

Nasal spray with glucose oxidase+glucose

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01883427

First Posted

April 23, 2013

Last Updated

December 7, 2015

Sponsor

Krister Tano

1. Study Identification

Unique Protocol Identification Number

NCT01883427

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

May 2013 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Krister Tano

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Respiratory Tract Infections

Keywords

Days with URTI symptoms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo: Saline+glucose nasal spray

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Nasal spray with glucose oxidase+glucose

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Baxter Rehydrex

Intervention Description

placebo containing saline+glucose

Intervention Type

Drug

Intervention Name(s)

Glucose oxidase

Other Intervention Name(s)

G2133, Sigmaaldrich

Intervention Description

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

Primary Outcome Measure Information:

Title

Respiratory Infectious Symptoms

Description

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

10. Eligibility

Sex

All

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Children below 4 years of age Exclusion Criteria: None

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eva Westman, MD, PhD

Organizational Affiliation

Västernorrlands Landsting

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Marie Ryding, MD, PhD

Organizational Affiliation

Jämtlands Landsting

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Anders Niklasson, MD

Organizational Affiliation

Norrbottens Landsting

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Helena Toolanen, MD

Organizational Affiliation

Norrbottens Landsting

Official's Role

Study Chair

Facility Information:

Facility Name

Öronmottagningen

City

Piteå

Country

Sweden

Facility Name

Öronmottagningen

City

Sunderbyn

Country

Sweden

Facility Name

Öronmottagningen

City

Sundsvall

Country

Sweden

Facility Name

Öronmottagningen

City

Östersund

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs