Glucose Oxidase as Treatment Against Common Cold

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Krister Tano, Umeå University
ClinicalTrials.gov Identifier:
NCT01883440
First received: April 23, 2013
Last updated: December 19, 2015
Last verified: December 2015
  Purpose

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.


Condition Intervention Phase
Common Cold
Drug: Glucose oxidase + glucose
Drug: Saline+glucose
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Sum of All Symptoms in Viruspositive Persons [ Time Frame: One week ] [ Designated as safety issue: Yes ]
    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.

  • Sum of All Symptoms of All Persons That Fullfilled the Study [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 90
Study Start Date: January 2013
Study Completion Date: September 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline+glucose
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
Placebo arm
Active Comparator: Glucose oxidase + glucose
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
Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of a common cold within the last 24 hours

Exclusion Criteria:

  • Use of a nasal steroid due to allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883440

Locations
Sweden
Öronmottagningen
Sunderbyn, Sweden
Sponsors and Collaborators
Krister Tano
Investigators
Study Chair: Helena Toolanen, MD Norrbottens Läns Landsting
  More Information

Responsible Party: Krister Tano, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01883440     History of Changes
Other Study ID Numbers: GOcoldSY2013 
Study First Received: April 23, 2013
Results First Received: April 16, 2015
Last Updated: December 19, 2015
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Umeå University:
Duration

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 23, 2016