Common ColdPhase 2NCT01883440

Glucose Oxidase as Treatment Against Common Cold

A Phase 2 study testing Glucose oxidase + glucose and Saline+glucose in people with Common Cold, run by Krister Tano at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Glucose oxidase is a hydrogen peroxide producing enzyme, which also is present in honey. Human rhinoviruses are sensitive to the action of hydrogen peroxide, which is documented in laboratory studies. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Common Cold
What is being tested?: Glucose oxidase + glucose and Saline+glucose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 90 participants
Where: 1 siteSweden
Study dates: Jan 2013to Sep 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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Symptoms of a common cold within the last 24 hours

Who cannot join

Use of a nasal steroid due to allergy

Trial locations and contacts

1 site in 1 country.

Sweden1 site

Öronmottagningen
Södra Sunderbyn

Other trials in Sweden

About this study

Official title: A Placebo Controlled Study With a Nasal Spray Containing Glucose Oxidase, Aiming to Induce a Faster Recovery From an Episode of Common Cold

In the present study we aim to investigate if a nasal spray with glucose oxidase could treat a common cold, when the treatment is started even after the onset of the symptoms. The study is randomized and placebo controlled.

Read the detailed description

Persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms.

Before they start the treatment with the nasal spray they perform a viral sample from the nose and also fill in the WURSS-21 protocol. After this the persons spray with glucose oxidase+glucose/only saline+glucose 5 times the first day and thereafter 3 times daily for a total treatment of one week. Every day the included persons fill in the WURSS-21 protocol.

Conditions: Common Cold
Being tested: Glucose oxidase + glucose, Saline+glucose
Keywords: Duration
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Glucose oxidase + glucoseDrug
Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
Saline+glucoseDrug
Placebo arm

Study groups in NCT01883440
Study group	Role	What they receive
Saline+glucose	Placebo comparator	A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week Receives: Drug: Saline+glucose
Glucose oxidase + glucose	Active comparator	A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week. Receives: Drug: Glucose oxidase + glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

Sum of All Symptoms in Viruspositive Persons
Symptoms of a common cold, recorded in a home protocol, "Wisconsin Upper Respiratory Symptom Score 21 (WURSS21)" daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day.
Measured: One week
Sum of All Symptoms of All Persons That Fullfilled the Study
Symptoms of a common cold, recorded in a home protocol, "Wisconsin Upper Respiratory Symptom Score 21 (WURSS21)" daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day.
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2013Sep 2013

First posted21 Jun 2013 (estimated)
Study startJan 2013
Primary completionAug 2013
Study completionSep 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 Common ColdStudies 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: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01883440
Sponsor's protocol ID: GOcoldSY2013
Status last verified: Dec 2015
First submitted: 23 Apr 2013
Last updated: 27 Jan 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Placebo Controlled Study With a Nasal Spray Containing Glucose Oxidase, Aiming to Induce a Faster Recovery From an Episode of Common Cold
ClinicalTrials.gov ID: NCT01883440
Acronym / sponsor ID: GOcoldSY2013
Conditions: Common Cold
Keywords: Duration
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Krister TanoUniversity, hospital or other
Study start: Jan 2013
Primary completion: Aug 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 21 Jun 2013 (estimated)
Results: Posted 27 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Persons that are convinced of that they have caught an episode of common cold can be included into the study within 24 hours after the onset of symptoms.

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
Saline+glucose	Placebo comparator	Drug: Saline+glucoseA nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
Glucose oxidase + glucose	Active comparator	Drug: Glucose oxidase + glucoseA nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Symptoms of a common cold within the last 24 hours

Key exclusion criteria (1 listed)

Use of a nasal steroid due to allergy

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
Glucose oxidase + glucoseIsotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device	Drug	Glucose oxidase + glucose
Saline+glucosePlacebo arm	Drug	Saline+glucose

Primary outcome

Sum of All Symptoms in Viruspositive Persons
Time frame: One week
Symptoms of a common cold, recorded in a home protocol, "Wisconsin Upper Respiratory Symptom Score 21 (WURSS21)" daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day.
Sum of All Symptoms of All Persons That Fullfilled the Study
Time frame: 7 days
Symptoms of a common cold, recorded in a home protocol, "Wisconsin Upper Respiratory Symptom Score 21 (WURSS21)" daily for 7 days was used as the evaluation method of the treatment. WURSS-21 is a validated protocol for assessing symptoms of a common cold. We used this protocol at start, before the persons in the study started their treatment and thereafter every day for the next 7 days. WURSS 21 consists of 21 questions (last question is not valid) regarding different symptoms as: running nose, sore throat, cough, blocked nose, etc. Every such question is graded from 0-7, 0 is defined as no such symptom and the number 7 means the worst possible symptom. The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol, which means that the value from each of the 20 questions (min=0, max=140) is summarized every day for each of the participants, which gives a mean value for both groups every day.

Results and safety

Results posted to the registry on 27 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Saline+Glucose	45	42
Glucose Oxidase + Glucose	45	45

Primary outcome: Sum of All Symptoms in Viruspositive Persons

Time frame: One week. Mean (Full Range). Unit: units on a scale

Measure	Saline+Glucose n = 14	Glucose Oxidase + Glucose n = 13
Start value	52 (8 to 63)	52 (18 to 92)
Value day 1	54 (8 to 84)	56 (14 to 81)
Value day 2	58 (13 to 95)	53 (8 to 108)
Value day 3	52.5 (7 to 80)	38 (2 to 106)
Value day 4	48 (2 to 83)	31 (0 to 87)
Value day 5	39 (0 to 99)	26 (0 to 71)
Value day 6	36 (0 to 96)	18 (0 to 77)
Value day 7	29 (0 to 61)	14 (0 to 72)

Saline+Glucose vs Glucose Oxidase + Glucose: p <0.037, Mixed Models Analysis

Population analysed: The persons analyzed were those that had a positive viral sampling with Parainfluenza, Corona or Rhinoviruses, that is: the viruses that most often causes common cold and also would be accessible for treatment with a nasal spray.

Primary outcome: Sum of All Symptoms of All Persons That Fullfilled the Study

Time frame: 7 days. Mean (Full Range). Unit: units on a scale

Measure	Saline+Glucose n = 42	Glucose Oxidase + Glucose n = 45
Start	42 (4 to 81)	42 (4 to 99)
Day 1	44 (5 to 84)	42 (6 to 104)
Day 2	45 (0 to 95)	39 (0 to 121)
Day 3	40 (0 to 84)	34 (0 to 123)
Day 4	33 (0 to 83)	31 (0 to 118)
Day 5	27 (0 to 99)	27 (0 to 74)
Day 6	21 (0 to 96)	23 (0 to 78)
Day 7	17 (0 to 61)	19 (0 to 78)

Saline+Glucose vs Glucose Oxidase + Glucose: p = 0.381, Mixed Models Analysis

Population analysed: All of the persons that fullfilled the study

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Saline+Glucose	0 of 45 (0%)	0 of 45 (0%)	Not reported
Glucose Oxidase + Glucose	0 of 45 (0%)	0 of 45 (0%)	Not reported

Limitations and caveats (from the sponsor): Viral samplings were made in order to exclude persons with no viral infection and persons with influenza. Most common Colds are due to Rhinoviruses, Parainfluenza and Coronaviruses. These persons were included in the Groups with significant findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 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.

Helena Toolanen, MD study chair

Norrbottens Läns Landsting

1 site 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 + glucose and Saline+glucose in people with Common Cold, run by Krister Tano at 1 site 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 27 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 1 site 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 27 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?

Sum of All Symptoms in Viruspositive Persons (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01883440.

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 27 Jan 2016; AzTrials last refreshed its copy on 6 Nov 2026.