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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

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 Drug: Glucose oxidase + glucose
Drug: Saline+glucose
Enrollment 90
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline+Glucose Glucose Oxidase + Glucose
Hide Arm/Group Description

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

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

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.

Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

Period Title: Overall Study
Started 45 45
Completed 42 45
Not Completed 3 0
Arm/Group Title Saline+Glucose Glucose Oxidase + Glucose Total
Hide Arm/Group Description

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

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

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.

Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

Total of all reporting groups
Overall Number of Baseline Participants 42 45 87
Hide Baseline Analysis Population Description
All persons that completed the 7 Days of treatment
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
42
 100.0%
45
 100.0%
87
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants 45 participants 87 participants
44
(18 to 63)
41
(21 to 61)
42
(18 to 63)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants 45 participants 87 participants
Female
33
  78.6%
35
  77.8%
68
  78.2%
Male
9
  21.4%
10
  22.2%
19
  21.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 42 participants 45 participants 87 participants
42 45 87
1.Primary Outcome
Title Sum of All Symptoms in Viruspositive Persons
Hide Description 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.
Time Frame One week
Hide Outcome Measure Data
Hide Analysis Population Description
The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.
Arm/Group Title Saline+Glucose Glucose Oxidase + Glucose
Hide Arm/Group Description:

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

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

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.

Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

Overall Number of Participants Analyzed 14 13
Mean (Full Range)
Unit of Measure: units on a scale
Start value
52
(8 to 63)
52
(18 to 92)
Value day 1
54
(8 to 84)
56
(14 to 81)
Value day 2
58
(13 to 95)
53
(8 to 108)
Value day 3
52.5
(7 to 80)
38
(2 to 106)
Value day 4
48
(2 to 83)
31
(0 to 87)
Value day 5
39
(0 to 99)
26
(0 to 71)
Value day 6
36
(0 to 96)
18
(0 to 77)
Value day 7
29
(0 to 61)
14
(0 to 72)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline+Glucose, Glucose Oxidase + Glucose
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.037
Comments [Not Specified]
Method Mixed Models Analysis
Comments Linear mixed model
2.Primary Outcome
Title Sum of All Symptoms of All Persons That Fullfilled the Study
Hide Description 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.
Time Frame 7 days
Hide Outcome Measure Data
Hide Analysis Population Description
All of the persons that fullfilled the study
Arm/Group Title Saline+Glucose Glucose Oxidase + Glucose
Hide Arm/Group Description:
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

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.

Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

Overall Number of Participants Analyzed 42 45
Mean (Full Range)
Unit of Measure: units on a scale
Start
42
(4 to 81)
42
(4 to 99)
Day 1
44
(5 to 84)
42
(6 to 104)
Day 2
45
(0 to 95)
39
(0 to 121)
Day 3
40
(0 to 84)
34
(0 to 123)
Day 4
33
(0 to 83)
31
(0 to 118)
Day 5
27
(0 to 99)
27
(0 to 74)
Day 6
21
(0 to 96)
23
(0 to 78)
Day 7
17
(0 to 61)
19
(0 to 78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Saline+Glucose, Glucose Oxidase + Glucose
Comments In the material when all were included, there were a lot of persons with few symptoms in both Groups, which means that a larger study would be needed in order to detect significant differences.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.381
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline+Glucose Glucose Oxidase + Glucose
Hide Arm/Group Description

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

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

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.

Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device

All-Cause Mortality
Saline+Glucose Glucose Oxidase + Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saline+Glucose Glucose Oxidase + Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (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 Glucose Oxidase + Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Viral samplings were made in order to exclude persons with no viral infection and persons with influenza. Most common Colds are due to Rhinoviruses, Parainfluenza and Coronaviruses. These persons were included in the Groups with significant findings.
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
Name/Title: MD, PhD Krister Tano
Organization: Umeå University
Phone: 0046705569043
Responsible Party: Krister Tano, Umeå University
ClinicalTrials.gov Identifier: NCT01883440     History of Changes
Other Study ID Numbers: GOcoldSY2013
First Submitted: April 23, 2013
First Posted: June 21, 2013
Results First Submitted: April 16, 2015
Results First Posted: January 27, 2016
Last Update Posted: January 27, 2016