Trial Outcomes & Findings for A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold (NCT NCT01883453)

Last Updated: 2015-11-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

146 participants

Primary outcome timeframe

One week

Results posted on

2015-11-09

Participant Flow

Participant milestones

Participant milestones
Measure	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 Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device	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. Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme
Overall Study STARTED	73	73
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	25	23

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device	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. Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme
Overall Study No episode of common cold	25	23

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Saline+Glucose Nasal Spray n=48 Participants 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	Nasal Spray With Glucose Oxidase+Glucose n=50 Participants 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 n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=5 Participants	48 Participants n=7 Participants	95 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	38 years n=5 Participants	40 years n=7 Participants	39 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	22 Participants n=7 Participants	40 Participants n=5 Participants
Region of Enrollment Sweden	48 participants n=5 Participants	50 participants n=7 Participants	98 participants n=5 Participants

PRIMARY outcome

Timeframe: One week

Population: 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.

Outcome measures

Outcome measures
Measure	Saline+Glucose Nasal Spray n=17 Participants 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	Nasal Spray With Glucose Oxidase+Glucose n=13 Participants 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
Reducing Symptoms of a Common Cold Start value	53 units on a scale Interval 22.0 to 84.0	53 units on a scale Interval 23.0 to 77.0
Reducing Symptoms of a Common Cold Value day 1	55 units on a scale Interval 22.0 to 85.0	54 units on a scale Interval 30.0 to 88.0
Reducing Symptoms of a Common Cold Value day 2	55 units on a scale Interval 23.0 to 84.0	49 units on a scale Interval 28.0 to 86.0
Reducing Symptoms of a Common Cold Value day 3	40 units on a scale Interval 6.0 to 85.0	36 units on a scale Interval 7.0 to 66.0
Reducing Symptoms of a Common Cold Value day 4	31 units on a scale Interval 0.0 to 77.0	29 units on a scale Interval 1.0 to 48.0
Reducing Symptoms of a Common Cold Value day 5	22 units on a scale Interval 0.0 to 73.0	20 units on a scale Interval 0.0 to 51.0
Reducing Symptoms of a Common Cold Value day 6	14 units on a scale Interval 0.0 to 59.0	14 units on a scale Interval 0.0 to 58.0
Reducing Symptoms of a Common Cold Value day 7	10 units on a scale Interval 0.0 to 56.0	12 units on a scale Interval 0.0 to 58.0

Adverse Events

Saline+Glucose Nasal Spray

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nasal Spray With Glucose Oxidase+Glucose

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Krister Tano

Umeå University

Phone: 0046705569043

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place