Trial Outcomes & Findings for Glucose Oxidase as Treatment Against Common Cold (NCT NCT01883440)
NCT ID: NCT01883440
Last Updated: 2016-01-27
Results Overview
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.
COMPLETED
PHASE2
90 participants
One week
2016-01-27
Participant Flow
Participant milestones
| Measure |
Saline+Glucose
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
|
Glucose Oxidase + Glucose
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 Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
42
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Glucose Oxidase as Treatment Against Common Cold
Baseline characteristics by cohort
| Measure |
Saline+Glucose
n=42 Participants
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
|
Glucose Oxidase + Glucose
n=45 Participants
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
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=39 Participants
|
45 Participants
n=41 Participants
|
87 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Continuous
|
44 years
n=39 Participants
|
41 years
n=41 Participants
|
42 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=39 Participants
|
35 Participants
n=41 Participants
|
68 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Region of Enrollment
Sweden
|
42 participants
n=39 Participants
|
45 participants
n=41 Participants
|
87 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: One weekPopulation: 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.
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.
Outcome measures
| Measure |
Saline+Glucose
n=14 Participants
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
|
Glucose Oxidase + Glucose
n=13 Participants
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
|
|---|---|---|
|
Sum of All Symptoms in Viruspositive Persons
Start value
|
52 units on a scale
Interval 8.0 to 63.0
|
52 units on a scale
Interval 18.0 to 92.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 1
|
54 units on a scale
Interval 8.0 to 84.0
|
56 units on a scale
Interval 14.0 to 81.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 3
|
52.5 units on a scale
Interval 7.0 to 80.0
|
38 units on a scale
Interval 2.0 to 106.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 5
|
39 units on a scale
Interval 0.0 to 99.0
|
26 units on a scale
Interval 0.0 to 71.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 2
|
58 units on a scale
Interval 13.0 to 95.0
|
53 units on a scale
Interval 8.0 to 108.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 4
|
48 units on a scale
Interval 2.0 to 83.0
|
31 units on a scale
Interval 0.0 to 87.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 6
|
36 units on a scale
Interval 0.0 to 96.0
|
18 units on a scale
Interval 0.0 to 77.0
|
|
Sum of All Symptoms in Viruspositive Persons
Value day 7
|
29 units on a scale
Interval 0.0 to 61.0
|
14 units on a scale
Interval 0.0 to 72.0
|
PRIMARY outcome
Timeframe: 7 daysPopulation: All of the persons that fullfilled the study
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.
Outcome measures
| Measure |
Saline+Glucose
n=42 Participants
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
|
Glucose Oxidase + Glucose
n=45 Participants
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
|
|---|---|---|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Start
|
42 units on a scale
Interval 4.0 to 81.0
|
42 units on a scale
Interval 4.0 to 99.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 1
|
44 units on a scale
Interval 5.0 to 84.0
|
42 units on a scale
Interval 6.0 to 104.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 2
|
45 units on a scale
Interval 0.0 to 95.0
|
39 units on a scale
Interval 0.0 to 121.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 3
|
40 units on a scale
Interval 0.0 to 84.0
|
34 units on a scale
Interval 0.0 to 123.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 4
|
33 units on a scale
Interval 0.0 to 83.0
|
31 units on a scale
Interval 0.0 to 118.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 5
|
27 units on a scale
Interval 0.0 to 99.0
|
27 units on a scale
Interval 0.0 to 74.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 6
|
21 units on a scale
Interval 0.0 to 96.0
|
23 units on a scale
Interval 0.0 to 78.0
|
|
Sum of All Symptoms of All Persons That Fullfilled the Study
Day 7
|
17 units on a scale
Interval 0.0 to 61.0
|
19 units on a scale
Interval 0.0 to 78.0
|
Adverse Events
Saline+Glucose
Glucose Oxidase + Glucose
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place