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Glucose Oxidase as Treatment Against Common Cold

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ClinicalTrials.gov Identifier: NCT01883440
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : January 27, 2016
Last Update Posted : January 27, 2016
Sponsor:
Information provided by (Responsible Party):
Krister Tano, Umeå University

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE June 21, 2013
Results First Submitted Date  ICMJE April 16, 2015
Results First Posted Date  ICMJE January 27, 2016
Last Update Posted Date January 27, 2016
Study Start Date  ICMJE January 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2015)
  • Sum of All Symptoms in Viruspositive Persons [ Time Frame: One week ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
Is it possible to shorten an episode of common cold with a nasal spray containing glucose oxidase? [ Time Frame: 130101 - 130901 ]
Symptoms of a common cold, recorded in a home protocol (WURSS21) daily for 7 days is used as evaluation method of the treatment.Wisconsin Upper Respiratory Symptom Score (WURSS-21)is a validated protocol for assessing symptoms of a common cold. We are using this protocol at start, before the persons in the study start their treatment and thereafter every day for the next 7 days, while they use the nasal spray(glucose oxidase+saline and glucose or only saline+glucose). The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol.
Change History Complete list of historical versions of study NCT01883440 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glucose Oxidase as Treatment Against Common Cold
Official Title  ICMJE A Placebo Controlled Study With a Nasal Spray Containing Glucose Oxidase, Aiming to Induce a Faster Recovery From an Episode of Common Cold
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Common Cold
Intervention  ICMJE
  • Drug: Glucose oxidase + glucose
    Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
  • Drug: Saline+glucose
    Placebo arm
Study Arms  ICMJE
  • 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
    Intervention: Drug: Saline+glucose
  • 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.
    Intervention: Drug: Glucose oxidase + glucose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
90
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Symptoms of a common cold within the last 24 hours

Exclusion Criteria:

  • Use of a nasal steroid due to allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883440
Other Study ID Numbers  ICMJE GOcoldSY2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krister Tano, Umeå University
Study Sponsor  ICMJE Krister Tano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Helena Toolanen, MD Norrbottens Läns Landsting
PRS Account Umeå University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP