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
|Condition or disease||Intervention/treatment||Phase|
|Upper Respiratory Tract Infections||Drug: Placebo Drug: Glucose oxidase||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||October 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||June 2013|
Placebo Comparator: Placebo: Saline+glucose nasal spray
Subjects received nasal spray containing both saline+glucose twice daily for 3 months
placebo containing saline+glucose
Other Name: 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 Name: G2133, Sigmaaldrich
- Respiratory Infectious Symptoms [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883427
|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|