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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

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE June 21, 2013
Results First Submitted Date  ICMJE April 16, 2015
Results First Posted Date  ICMJE January 11, 2016
Last Update Posted Date January 11, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2013)
Does a nasal spray with glucose oxidase reduce number of days with upper respiratory infectious symptoms and/or episodes of acute otitis media? [ Time Frame: 3 months of recording ]
Upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.
Change History Complete list of historical versions of study NCT01883427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Upper Respiratory Tract Infections
Intervention  ICMJE
  • Drug: Placebo
    placebo containing saline+glucose
    Other Name: Baxter Rehydrex
  • Drug: Glucose oxidase
    a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
    Other Name: G2133, Sigmaaldrich
Study Arms  ICMJE
  • Placebo Comparator: Placebo: Saline+glucose nasal spray
    Subjects received nasal spray containing both saline+glucose twice daily for 3 months
    Intervention: Drug: Placebo
  • 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.
    Intervention: Drug: Glucose oxidase
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children below 4 years of age

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 3 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01883427
Other Study ID Numbers  ICMJE GObarn2013
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Krister Tano, Umeå University
Study Sponsor  ICMJE Krister Tano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Umeå University
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP