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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01883453
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
Information provided by (Responsible Party):
Krister Tano, Umeå University

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.

Condition or disease Intervention/treatment Phase
Common Cold Device: Glucose oxidase+5%glucose Device: Saline+5%glucose Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blinded Clinical Study Aiming to Shorten an Episode of Common Cold When the Treatment is Started at the Onset of an Episode of Common Cold
Study Start Date : January 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Common Cold
Drug Information available for: Dextrose

Arm Intervention/treatment
Placebo Comparator: 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
Device: Saline+5%glucose
Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

Active Comparator: 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.
Device: Glucose oxidase+5%glucose
A hydrogen peroxide producing enzyme

Primary Outcome Measures :
  1. Reducing Symptoms of a Common Cold [ Time Frame: One week ]

    Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common Cold.

    WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • Ongoing allergy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01883453

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Boden, Sweden
Umeå, Sweden
Sponsors and Collaborators
Umeå University
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Principal Investigator: Krister Tano, MD,PhD Umeå University

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Responsible Party: Krister Tano, MD, PhD, Umeå University Identifier: NCT01883453     History of Changes
Other Study ID Numbers: GOcoldU&B2013
First Posted: June 21, 2013    Key Record Dates
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases