A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold

NCT ID: NCT01883453

Last Updated: 2015-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-09-30

Brief Summary

Healthy persons are invited to participate in the study and are given a home protocol (WURSS21), nasal spray and a sample pin. The included persons are told to make a nasopharyngeal sampling from the nose when they are sure that they have caught a common cold. After the sampling they start to spray and also fill in the records daily. The aim of the study is to investigate whether a nasal spray with glucose oxidase could shorten an episode of common cold.

Detailed Description

Persons working in a military unit in Boden and persons connected to the Department of Sports Medicine in Umeå were invited to participate in this study. Only persons older than 18 years was included in the study. The persons included received one bottle of study medicine, a home protocol (WURSS 21) and a viral sampling kit. Whenever the included persons were sure that they had received an episode of common cold they were told to perform a viral sampling from the nose, fill in the protocol and start to use the nasal spray several times daily for one week. The treatment was either a) a saline solution with 5% glucose or b) a saline solution with 200U/ml of glucose oxidase and 5%glucose (active treatment group). The combination of glucose oxidase and glucose produces an acid environment, imitating the effect of the normal nasal flora and Human Rhinoviruses are sensitive to an acid environment. After one week of treatment and daily records of the WURSS 21 protocol the persons returned the spray bottles (Bag-on-Valve), the virus vials and the protocols.

A total of 146 persons were included in the study and 98 persons returned protocols.

Conditions

Common Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Saline+glucose nasal spray

A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week

Group Type: PLACEBO_COMPARATOR

Saline+5%glucose

Intervention Type: DEVICE

Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

Nasal spray with glucose oxidase+glucose

A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.

Group Type: ACTIVE_COMPARATOR

Glucose oxidase+5%glucose

Intervention Type: DEVICE

A hydrogen peroxide producing enzyme

Interventions

Saline+5%glucose

Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

Intervention Type: DEVICE

Glucose oxidase+5%glucose

A hydrogen peroxide producing enzyme

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Healthy adults

Exclusion Criteria

• Ongoing allergy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Krister Tano

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krister Tano, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Försvarshälsan

Boden, , Sweden

Idrottsmedicin

Umeå, , Sweden

Countries

Sweden

Other Identifiers

GOcoldU&B2013

Identifier Type: -

Identifier Source: org_study_id