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

December 7, 2015 updated by: Krister Tano

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

To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Piteå, Sweden
        • Öronmottagningen
      • Sunderbyn, Sweden
        • Öronmottagningen
      • Sundsvall, Sweden
        • Öronmottagningen
      • Östersund, Sweden
        • Öronmottagningen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children below 4 years of age

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo: Saline+glucose nasal spray
Subjects received nasal spray containing both saline+glucose twice daily for 3 months
Drug: Placebo
placebo containing saline+glucose
Other Names:
  • Baxter Rehydrex
Active Comparator: 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.
Drug: Glucose oxidase
a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
Other Names:
  • G2133, Sigmaaldrich

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Respiratory Infectious Symptoms
Time Frame: 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.
3 months of recording

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krister Tano

Investigators

  • Study Chair: Eva Westman, MD, PhD, Västernorrlands Landsting
  • Study Chair: Marie Ryding, MD, PhD, Jämtlands Landsting
  • Study Chair: Anders Niklasson, MD, Norrbottens Landsting
  • Study Chair: Helena Toolanen, MD, Norrbottens Landsting

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

June 20, 2013

First Posted (Estimate)

June 21, 2013

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

December 7, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GObarn2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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