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

Upper Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883427
• Other study ID #: GObarn2013
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2013
• Last updated: December 7, 2015
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2015
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 3 Years

Eligibility

Inclusion Criteria:

• Children below 4 years of age

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Intervention

Drug:
• Placebo
placebo containing saline+glucose
• Glucose oxidase
a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.

Locations

Country	Name	City	State
Sweden	Öronmottagningen	Östersund
Sweden	Öronmottagningen	Piteå
Sweden	Öronmottagningen	Sunderbyn
Sweden	Öronmottagningen	Sundsvall

Sponsors (1)

Lead Sponsor	Collaborator
Krister Tano

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months of recording	Yes