Glucose Oxidase as Treatment Against Common Cold

Common Cold Clinical Trial

Official title:

A Placebo Controlled Study With a Nasal Spray Containing Glucose Oxidase, Aiming to Induce a Faster Recovery From an Episode of Common Cold

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883440
• Other study ID #: GOcoldSY2013
• Status: Completed
• Phase: Phase 2
• First received: April 23, 2013
• Last updated: December 19, 2015
• Start date: January 2013
• Est. completion date: September 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

Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey. Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in laboratory studies.

In the present study we aim to investigate if a nasal spray with glucose oxidase could treat a common cold, when the treatment is started even after the onset of the symptoms. The study is randomized and placebo controlled.

Description:

Persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms.

Before they start the treatment with the nasal spray they perform a viral sample from the nose and also fill in the WURSS-21 protocol. After this the persons spray with glucose oxidase+glucose/only saline+glucose 5 times the first day and thereafter 3 times daily for a total treatment of one week. Every day the included persons fill in the WURSS-21 protocol.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Symptoms of a common cold within the last 24 hours

Exclusion Criteria:

• Use of a nasal steroid due to allergy

Study Design

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

Related Conditions & MeSH terms

• Common Cold

Intervention

Drug:
• Glucose oxidase + glucose
Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
• Saline+glucose
Placebo arm

Locations

Country	Name	City	State
Sweden	Öronmottagningen	Sunderbyn

Sponsors (1)

Lead Sponsor	Collaborator
Krister Tano

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sum of All Symptoms in Viruspositive Persons	Symptoms of a common cold, recorded in a home protocol, "Wisconsin Upper Respiratory Symptom Score 21 (WURSS21)" daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day.	One week	Yes
Primary	Sum of All Symptoms of All Persons That Fullfilled the Study	Symptoms of a common cold, recorded in a home protocol, "Wisconsin Upper Respiratory Symptom Score 21 (WURSS21)" daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day.	7 days	Yes