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

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ClinicalTrials.gov Identifier: NCT01883427
Recruitment Status : Completed
First Posted : June 21, 2013
Results First Posted : January 11, 2016
Last Update Posted : January 11, 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 Upper Respiratory Tract Infections
Interventions Drug: Placebo
Drug: Glucose oxidase
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Hide 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
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose Total
Hide 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 Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
Pre-school children
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
20
 100.0%
20
 100.0%
40
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Months
Number Analyzed 20 participants 20 participants 40 participants
28
(14 to 43)
27
(11 to 44)
28
(11 to 44)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
8
  40.0%
9
  45.0%
17
  42.5%
Male
12
  60.0%
11
  55.0%
23
  57.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Sweden Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title Respiratory Infectious Symptoms
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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

Overall Number of Participants Analyzed 20 20
Mean (Standard Deviation)
Unit of Measure: days
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)
Show Statistical Analysis 1 Hide 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 [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments Not significant
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame During the study period of 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Hide 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 (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Saline+Glucose Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (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 Nasal Spray Nasal Spray With Glucose Oxidase+Glucose
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
local side effects  [1]  0/20 (0.00%)  0/20 (0.00%) 
Indicates events were collected by systematic assessment
[1]
Local side effects in the nasal cavity
We wanted 200 Children but only 40 fulfilled the study, which make the results hard to evaluate.
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
Layout table for Results Point of Contact information
Name/Title: MD, PhD Krister Tano
Organization: Umeå University
Phone: 0046705569043
EMail: krister.tano@umu.se
Layout table for additonal information
Responsible Party: Krister Tano, Umeå University
ClinicalTrials.gov Identifier: NCT01883427     History of Changes
Other Study ID Numbers: GObarn2013
First Submitted: April 23, 2013
First Posted: June 21, 2013
Results First Submitted: April 16, 2015
Results First Posted: January 11, 2016
Last Update Posted: January 11, 2016