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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Common Cold
Interventions Device: Glucose oxidase+5%glucose
Device: Saline+5%glucose
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Hide Arm/Group 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

Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

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.

Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme

Period Title: Overall Study
Started 73 73
Completed 48 50
Not Completed 25 23
Reason Not Completed
No episode of common cold             25             23
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose Total
Hide Arm/Group 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

Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

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.

Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme

Total of all reporting groups
Overall Number of Baseline Participants 48 50 98
Hide Baseline Analysis Population Description
Healthy adult volunteers. One part of the included participants was from an education in elite skiing at the University and one part was from a military unit. The participants were told to start the treatment as soon as they were convinced that they had caught a common cold
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 50 participants 98 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
47
  97.9%
48
  96.0%
95
  96.9%
>=65 years
1
   2.1%
2
   4.0%
3
   3.1%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 48 participants 50 participants 98 participants
38
(19 to 72)
40
(18 to 70)
39
(18 to 72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 50 participants 98 participants
Female
30
  62.5%
28
  56.0%
58
  59.2%
Male
18
  37.5%
22
  44.0%
40
  40.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 48 participants 50 participants 98 participants
48 50 98
1.Primary Outcome
Title Reducing Symptoms of a Common Cold
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only the participants that fullfilled the study and who had a positive virus sample (Influensa and adenoviruses excluded) were included in the results. These are the participants that are supposed to benefit from a nasal spray with GO.
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Hide Arm/Group 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

Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

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.

Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme

Overall Number of Participants Analyzed 17 13
Mean (Full Range)
Unit of Measure: units on a scale
Start value
53
(22 to 84)
53
(23 to 77)
Value day 1
55
(22 to 85)
54
(30 to 88)
Value day 2
55
(23 to 84)
49
(28 to 86)
Value day 3
40
(6 to 85)
36
(7 to 66)
Value day 4
31
(0 to 77)
29
(1 to 48)
Value day 5
22
(0 to 73)
20
(0 to 51)
Value day 6
14
(0 to 59)
14
(0 to 58)
Value day 7
10
(0 to 56)
12
(0 to 58)
Time Frame January 2013 to May 2013
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Hide Arm/Group 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

Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

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.

Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme

All-Cause Mortality
Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/48 (0.00%)   0/50 (0.00%) 
Too few virus positive persons in order to get significant results. Local side effects were mild and about the same as in the placebo Group. Influensa season and few rhinovirus infections.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Krister Tano
Organization: Umeå University
Phone: 0046705569043
EMail: krister.tano@umu.se
Layout table for additonal information
Responsible Party: Krister Tano, Umeå University
ClinicalTrials.gov Identifier: NCT01883453     History of Changes
Other Study ID Numbers: GOcoldU&B2013
First Submitted: April 23, 2013
First Posted: June 21, 2013
Results First Submitted: April 20, 2015
Results First Posted: November 9, 2015
Last Update Posted: November 9, 2015