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

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ClinicalTrials.gov Identifier: NCT01883427
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : January 11, 2016
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Krister Tano, Umeå University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Upper Respiratory Tract Infections Drug: Placebo Drug: Glucose oxidase Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : October 2012
Actual Primary Completion Date : May 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arms and Interventions
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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 Name: 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 Name: G2133, Sigmaaldrich


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children below 4 years of age

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883427


Locations
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Sweden
Öronmottagningen
Piteå, Sweden
Öronmottagningen
Sunderbyn, Sweden
Öronmottagningen
Sundsvall, Sweden
Öronmottagningen
Östersund, Sweden
Sponsors and Collaborators
Krister Tano
Investigators
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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
More Information
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Responsible Party: Krister Tano, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01883427     History of Changes
Other Study ID Numbers: GObarn2013
First Posted: June 21, 2013    Key Record Dates
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016
Last Verified: December 2015

Keywords provided by Krister Tano, Umeå University:
Days with URTI symptoms

Additional relevant MeSH terms:
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Infection
Respiratory Tract Infections
Respiratory Tract Diseases