Glucose Oxidase as Treatment Against Common Cold

NCT01883440 | Completed Phase 2 Results DMC

• 1 other identifier: GOcoldSY2013
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Common Cold

Keywords

Duration

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Saline+glucose

PLACEBO COMPARATOR

A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week

Drug: Saline+glucose

Glucose oxidase + glucose

ACTIVE COMPARATOR

A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.

Drug: Glucose oxidase + glucose

Interventions

Glucose oxidase + glucose DRUG

Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

Glucose oxidase + glucose

Saline+glucose DRUG

Placebo arm

Saline+glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptoms of a common cold within the last 24 hours

You may not qualify if:

• Use of a nasal steroid due to allergy

Sponsors & Collaborators

• Krister Tano: lead

Study Sites (1)

Öronmottagningen

Södra Sunderbyn, Sweden

Location

MeSH Terms

Conditions

Common Cold

Interventions

Glucose Oxidase

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Alcohol Oxidoreductases; Oxidoreductases; Enzymes; Enzymes and Coenzymes

Limitations and Caveats

Viral samplings were made in order to exclude persons with no viral infection and persons with influenza. Most common Colds are due to Rhinoviruses, Parainfluenza and Coronaviruses. These persons were included in the Groups with significant findings.

Results Point of Contact

• Title: MD, PhD Krister Tano
• Organization: Umeå University

krister.tano@umu.se

0046705569043

Study Officials

• Helena Toolanen, MD

  Norrbottens Läns Landsting

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: June 21, 2013
• Study Start: January 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: January 27, 2016
• Results First Posted: January 27, 2016

Record last verified: 2015-12

Locations

SE (1)