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

Krister Tano

Status and phase: Completed; Phase 2

Conditions: Upper Respiratory Tract Infections

Treatments: Drug: Placebo; Drug: Glucose oxidase

Study type: Interventional

Funder types: Other

Identifiers

NCT01883427

GObarn2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: Under 3 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Children below 4 years of age

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups, including a placebo group

Placebo: Saline+glucose nasal spray

Placebo Comparator group

Description:

Subjects received nasal spray containing both saline+glucose twice daily for 3 months

Treatment:

Drug: Placebo

Nasal spray with glucose oxidase+glucose

Active Comparator group

Description:

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.

Treatment:

Drug: Glucose oxidase