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

• 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: Krister Tano
• Information provided by (Responsible Party): Krister Tano, Umeå University

Tracking Information

• First Submitted Date: April 23, 2013
• First Posted Date: June 21, 2013
• Results First Submitted Date: April 16, 2015
• Results First Posted Date: January 11, 2016
• Last Update Posted Date: January 11, 2016
• Study Start Date: October 2012
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Upper Respiratory Tract Infections

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 20, 2013): 40
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Children below 4 years of age

Exclusion Criteria:

• None

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 3 Years (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT01883427
• Other Study ID Numbers: GObarn2013
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Krister Tano, Umeå University
• Study Sponsor: Krister Tano
• Collaborators: Not Provided

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

• PRS Account: Umeå University
• Verification Date: December 2015