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

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ClinicalTrials.gov Identifier: NCT01883453
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : November 9, 2015
Last Update Posted : November 9, 2015
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 20, 2015
Results First Posted Date  ICMJE November 9, 2015
Last Update Posted Date November 9, 2015
Study Start Date  ICMJE January 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2013)
Reduced symptoms of a common cold [ Time Frame: 20130101 - 20130430 ]
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 NCT01883453 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 A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold
Official Title  ICMJE 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
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.
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.

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
  • Device: Glucose oxidase+5%glucose
    A hydrogen peroxide producing enzyme
  • Device: Saline+5%glucose
    Isotonic saline + 5% glucose in a bag-on-valve nasal spray device
Study Arms  ICMJE
  • 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
    Intervention: Device: Saline+5%glucose
  • 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.
    Intervention: Device: Glucose oxidase+5%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: October 9, 2015)
146
Original Estimated Enrollment  ICMJE
 (submitted: June 18, 2013)
150
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • Ongoing allergy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
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 NCT01883453
Other Study ID Numbers  ICMJE GOcoldU&B2013
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 Umeå University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Krister Tano, MD,PhD Umeå University
PRS Account Umeå University
Verification Date June 2015

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