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Completed

NCT Number: NCT01883427

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

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

Completed

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Key information

Conditions

Upper Respiratory Tract Infections Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

Up to 3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Öronmottagningen, Piteå, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children below 4 years of age

Exclusion criteria

  • None

Treatment and study plan

Placebo

Drug

placebo containing saline+glucose

Other names: Baxter Rehydrex

Glucose oxidase

Drug

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

Other names: G2133, Sigmaaldrich

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Krister Tano

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2013
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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