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

• Sponsor: Krister Tano (Other)
• Overall Status: Completed
• CT.gov ID: NCT01883427
• Collaborator: (none)
• Enrollment: 40
• Locations: 4
• Arms: 2
• Duration (Months): 8
• Patients Per Site: 10
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.

Condition or Disease	Intervention/Treatment	Phase
Upper Respiratory Tract Infections	Drug: Placebo; Drug: Glucose oxidase	Phase 2

Detailed Description

Children below 4 years of age and in public day care were invited to participate in this prospective study. The children started with a visit to an ENT doctor and after inclusion the children started to spray twice daily with glucose oxidase+glucose or only saline+glucose for 3 months. During this period the parents were asked to fill in a home protocol recording upper respiratory tract symptoms as: rhinitis, cough, fever, ear ache. After 6 weeks and 12 weeks the children had scheduled visits to the ENT department, where an ENT doctor examined the throat, nasal cavity and the ear drums for otitis media. After 12 weeks of treatment a nasopharyngeal swab was taken for bacterial culture.

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Placebo Controlled Study Among Children Below Four Years of Age, Investigating Whether a Glucose Oxidase Nasal Spray Can Reduce Days With Upper Respiratory Tract Infection Symptoms
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo: Saline+glucose nasal spray Subjects received nasal spray containing both saline+glucose twice daily for 3 months	Drug: Placebo; placebo containing saline+glucose; Other Names: Baxter Rehydrex
Active Comparator: Nasal spray with glucose oxidase+glucose Nasal spray in a bag-on-valve device with 50U/ml containing both glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.	Drug: Glucose oxidase; a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.; Other Names: G2133, Sigmaaldrich

Outcome Measures

Primary Outcome Measures

1. Respiratory Infectious Symptoms [3 months of recording]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 3 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Children below 4 years of age

Exclusion Criteria:

• None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Öronmottagningen	Piteå		Sweden
2	Öronmottagningen	Sunderbyn		Sweden
3	Öronmottagningen	Sundsvall		Sweden
4	Öronmottagningen	Östersund		Sweden

Sponsors and Collaborators

• Krister Tano

Investigators

• Study Chair: Eva Westman, MD, PhD, Västernorrlands Landsting
• Study Chair: Marie Ryding, MD, PhD, Jämtlands Landsting
• Study Chair: Anders Niklasson, MD, Norrbottens Landsting
• Study Chair: Helena Toolanen, MD, Norrbottens Landsting

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Krister Tano, MD, PhD, Umeå University
• ClinicalTrials.gov Identifier: NCT01883427
• Other Study ID Numbers: GObarn2013
• First Posted: Jun 21, 2013
• Last Update Posted: Jan 11, 2016
• Last Verified: Dec 1, 2015

• Keywords provided by Krister Tano, MD, PhD, Umeå University: Days with URTI symptoms
• Additional relevant MeSH terms: Infections; Respiratory Tract Infections

Study Results

Participant Flow

Arm/Group Title	Saline+Glucose Nasal Spray	Nasal Spray With Glucose Oxidase+Glucose
Arm/Group Description	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 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
Period Title: Overall Study
STARTED	20	20
COMPLETED	20	20
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Saline+Glucose Nasal Spray	Nasal Spray With Glucose Oxidase+Glucose	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	20	20	40
Age (Count of Participants)
<=18 years	20 100%	20 100%	40 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (months) [Mean (Full Range) ]
Mean (Full Range) [months]	28	27	28
Sex: Female, Male (Count of Participants)
Female	8 40%	9 45%	17 42.5%
Male	12 60%	11 55%	23 57.5%
Region of Enrollment (participants) [Number]
Sweden	20 100%	20 100%	40 100%

Outcome Measures

1. Primary Outcome

Title	Respiratory Infectious Symptoms
Description	Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.
Time Frame	3 months of recording

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Saline+Glucose Nasal Spray	Nasal Spray With Glucose Oxidase+Glucose
Arm/Group Description	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 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
Measure Participants	20	20
Days with URTI	9 (4)	13 (10)
Days with rhinitis	10 (6)	13 (10)
Days with cough and rhinitis	6 (5)	8 (6)
days with fever	3 (3)	5 (4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Saline+Glucose Nasal Spray, Nasal Spray With Glucose Oxidase+Glucose
	Comments	Too few included to reach power
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	>0.05
	Comments	Not significant
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	During the study period of 3 months
Arm/Group Title	Saline+Glucose Nasal Spray		Nasal Spray With Glucose Oxidase+Glucose
Arm/Group Description	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 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
All Cause Mortality
	Saline+Glucose Nasal Spray		Nasal Spray With Glucose Oxidase+Glucose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Saline+Glucose Nasal Spray		Nasal Spray With Glucose Oxidase+Glucose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Other (Not Including Serious) Adverse Events
	Saline+Glucose Nasal Spray		Nasal Spray With Glucose Oxidase+Glucose
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/20 (0%)
Respiratory, thoracic and mediastinal disorders
local side effects	0/20 (0%)		0/20 (0%)

Limitations/Caveats

We wanted 200 Children but only 40 fulfilled the study, which make the results hard to evaluate.

More Information

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.