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

• 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: Krister Tano
• Information provided by (Responsible Party): Krister Tano, Umeå University

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.

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

• 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

Arms and Interventions

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

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

• 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

Locations

Sweden

Öronmottagningen

Piteå, Sweden

Öronmottagningen

Sunderbyn, Sweden

Öronmottagningen

Sundsvall, Sweden

Öronmottagningen

Östersund, Sweden

Sponsors and Collaborators

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

More Information

• Responsible Party: Krister Tano, MD, PhD, Umeå University
• ClinicalTrials.gov Identifier: NCT01883427
• Other Study ID Numbers: GObarn2013
• First Posted: June 21, 2013
• 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:

Infection; Respiratory Tract Infections; Respiratory Tract Diseases