A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold
Primary Purpose
Common Cold
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Glucose oxidase+5%glucose
Saline+5%glucose
Sponsored by
About this trial
This is an interventional treatment trial for Common Cold
Eligibility Criteria
Inclusion Criteria:
- Healthy adults
Exclusion Criteria:
- Ongoing allergy
Sites / Locations
- Försvarshälsan
- Idrottsmedicin
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Saline+glucose nasal spray
Nasal spray with glucose oxidase+glucose
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Reducing Symptoms of a Common Cold
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01883453
Brief Title
A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold
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 Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Umeå University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Cold
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Saline+glucose nasal spray
Arm Type
Placebo Comparator
Arm Description
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
Arm Title
Nasal spray with glucose oxidase+glucose
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Glucose oxidase+5%glucose
Intervention Description
A hydrogen peroxide producing enzyme
Intervention Type
Device
Intervention Name(s)
Saline+5%glucose
Intervention Description
Isotonic saline + 5% glucose in a bag-on-valve nasal spray device
Primary Outcome Measure Information:
Title
Reducing Symptoms of a Common Cold
Description
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.
Time Frame
One week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adults
Exclusion Criteria:
Ongoing allergy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krister Tano, MD,PhD
Organizational Affiliation
Umeå University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Försvarshälsan
City
Boden
Country
Sweden
Facility Name
Idrottsmedicin
City
Umeå
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold
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