Trial Outcomes & Findings for Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children (NCT NCT01883427)

Last Updated: 2016-01-11

Results Overview

Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

40 participants

Primary outcome timeframe

3 months of recording

Results posted on

2016-01-11

Participant milestones
Measure	Saline+Glucose Nasal Spray Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose	Nasal Spray With Glucose Oxidase+Glucose Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children

Baseline characteristics by cohort
Measure	Saline+Glucose Nasal Spray n=20 Participants Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose	Nasal Spray With Glucose Oxidase+Glucose n=20 Participants Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28 months n=5 Participants	27 months n=7 Participants	28 months n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Region of Enrollment Sweden	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

Timeframe: 3 months of recording

Population: Only a total of 40 Children fulfilled the study, which means that the Power are to low.

Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.

Outcome measures
Measure	Saline+Glucose Nasal Spray n=20 Participants Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose	Nasal Spray With Glucose Oxidase+Glucose n=20 Participants Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx
Respiratory Infectious Symptoms Days with URTI	9 days Standard Deviation 4	13 days Standard Deviation 10
Respiratory Infectious Symptoms Days with rhinitis	10 days Standard Deviation 6	13 days Standard Deviation 10
Respiratory Infectious Symptoms Days with cough and rhinitis	6 days Standard Deviation 5	8 days Standard Deviation 6
Respiratory Infectious Symptoms days with fever	3 days Standard Deviation 3	5 days Standard Deviation 4

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Saline+Glucose Nasal Spray n=20 participants at risk Nasal spray with saline+glucose twice daily for 3 months Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose	Nasal Spray With Glucose Oxidase+Glucose n=20 participants at risk Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months. Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx
Respiratory, thoracic and mediastinal disorders local side effects	0.00% 0/20 • During the study period of 3 months	0.00% 0/20 • During the study period of 3 months

Umeå University

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