Glucose Oxidase as Treatment Against Common Cold
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.
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.
Other: Glucose oxidase + glucose
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Is it possible to shorten an episode of common cold with a nasal spray containing glucose oxidase? [ Time Frame: One week ] [ Designated as safety issue: Yes ]Symptoms of a common cold, recorded in a home protocol (WURSS21) daily for 7 days is used as evaluation method of the treatment.Wisconsin Upper Respiratory Symptom Score (WURSS-21)is a validated protocol for assessing symptoms of a common cold. We are using this protocol at start, before the persons in the study start their treatment and thereafter every day for the next 7 days, while they use the nasal spray(glucose oxidase+saline and glucose or only saline+glucose). The outcome measure is predominantly calculated as "the sum of all symptoms" in the WURSS-21 protocol.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Placebo Comparator: Saline+glucose
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
Isotone saline+5%glucose in a bag-on-valve nasal spray device
Other Name: Nasal spray containing isotonic saline+5% glucose
Active Comparator: Glucose oxidase + glucose
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.
Other: Glucose oxidase + glucose
Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
Other Name: A nasal spray containing isotonic saline+glucose oxidase+5% glucose
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01883440
|Contact: Krister Tano, MD, PhDemail@example.com|
|Contact: Helena Toolanen, MD firstname.lastname@example.org|
|Principal Investigator: Helena Toolanen, MD|
|Study Chair:||Helena Toolanen, MD||Norrbottens Läns Landsting|