Upper Respiratory Tract InfectionsPhase 2NCT01883427
Nasal Spray With Glucose Oxidase Preventing Common Cold in Pre-school Children
A Phase 2 study testing Glucose oxidase in people with Upper Respiratory Tract Infections, run by Krister Tano at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections
- What is being tested?
- Glucose oxidase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 4 sitesSweden
- Study dates
- Oct 2012to Jun 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children below 4 years of age
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Öronmottagningen
Östersund
Öronmottagningen
Piteå
Öronmottagningen
Södra Sunderbyn
Öronmottagningen
Sundsvall
About this study
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
To investigate if use of glucosoxidas nasal spray can reduce the number of days with upper respiratory tract infections in children beyond 4 years.
Read the 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.
- Conditions
- Upper Respiratory Tract Infections
- Being tested
- Placebo, Glucose oxidase
- Keywords
- Days with URTI symptoms
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Baxter Rehydrex
placebo containing saline+glucose
Glucose oxidaseDrug
Also called G2133, Sigmaaldrich
a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
| Study group | Role | What they receive |
|---|---|---|
| Placebo: Saline+glucose nasal spray | Placebo comparator | Subjects received nasal spray containing both saline+glucose twice daily for 3 months Receives: Drug: Placebo |
| Nasal spray with glucose oxidase+glucose | Active comparator | 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. Receives: Drug: Glucose oxidase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory Infectious Symptoms
Days with upper respiratory tract infection symptoms during a 3 months period are recorded in a home protocol by the parents of the children.
Measured: 3 months of recording
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startOct 2012
- Primary completionMay 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Upper Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Krister Tano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Krister Tano, Umeå University
- Investigators
- Eva Westman, MD, PhD, Study chair, Västernorrlands LandstingMarie Ryding, MD, PhD, Study chair, Jämtlands LandstingAnders Niklasson, MD, Study chair, Norrbottens LandstingHelena Toolanen, MD, Study chair, Norrbottens Landsting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883427
- Sponsor's protocol ID
- GObarn2013
- Status last verified
- Dec 2015
- First submitted
- 23 Apr 2013
- Last updated
- 11 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01883427
- Acronym / sponsor ID
- GObarn2013
- Conditions
- Upper Respiratory Tract Infections
- Keywords
- Days with URTI symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Krister TanoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- May 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 21 Jun 2013 (estimated)
- Results
- Posted 11 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo: Saline+glucose nasal spray | Placebo comparator | Drug: PlaceboSubjects received nasal spray containing both saline+glucose twice daily for 3 months |
| Nasal spray with glucose oxidase+glucose | Active comparator | Drug: Glucose oxidaseNasal 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. |
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children below 4 years of age
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Baxter Rehydrexplacebo containing saline+glucose | Drug | Placebo: Saline+glucose nasal spray |
| Glucose oxidaseAlso: G2133, Sigmaaldricha hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive. | Drug | Nasal spray with glucose oxidase+glucose |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Westman, MD, PhD study chair
Västernorrlands Landsting
Marie Ryding, MD, PhD study chair
Jämtlands Landsting
Anders Niklasson, MD study chair
Norrbottens Landsting
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Glucose oxidase in people with Upper Respiratory Tract Infections, run by Krister Tano at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Respiratory Infectious Symptoms (time frame: 3 months of recording). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.