A Nasal Spray With Glucose Oxidase as a Treatment of Common Cold

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Umeå University
Sponsor:
Information provided by (Responsible Party):
Krister Tano, Umeå University
ClinicalTrials.gov Identifier:
NCT01883453
First received: April 23, 2013
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

Healthy persons are invited to participate in the study and are given a home protocol (WURSS21), nasal spray and a sample pin. The included persons are told to make a nasopharyngeal sampling from the nose when they are sure that they have caught a common cold. After the sampling they start to spray and also fill in the records daily. The aim of the study is to investigate whether a nasal spray with glucose oxidase could shorten an episode of common cold.


Condition Intervention Phase
Reducing Symptoms of a Common Cold
Other: Glucose oxidase+glucose
Other: Saline+glucose
Phase 2

Study Type: Interventional
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 Double Blinded Clinical Study Aiming to Shorten an Episode of Common Cold When the Treatment is Started at the Onset of an Episode of Common Cold

Resource links provided by NLM:


Further study details as provided by Umeå University:

Primary Outcome Measures:
  • Reducing symptoms of a common cold [ Time Frame: One week ] [ Designated as safety issue: Yes ]
    Using the Wisconsin Upper Respiratory Symptom Score (WURSS-21)it is possible to assess if a nasal spray containing glucose oxidase and glucose would be able to reduce symptoms of a common cold


Estimated Enrollment: 150
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline+glucose nasal spray
A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week
Other: Saline+glucose
Isotonic saline + 5% glucose in a bag-on-valve nasal spray device
Other Name: Nasal spray with isotonic saline + 5% glucose
Active Comparator: Nasal spray with glucose oxidase+glucose
A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.
Other: Glucose oxidase+glucose
A hydrogen peroxide producing enzyme
Other Name: Nasal spray containing saline solution+glucose oxidase+5%glucose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adults

Exclusion Criteria:

  • Ongoing allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01883453

Contacts
Contact: Krister Tano, MD, PhD 00465569043 krister.tano@nll.se

Locations
Sweden
Försvarshälsan Recruiting
Boden, Sweden
Contact: Liselott Tano, MD       liselott.tano@mil.se   
Principal Investigator: Liselott Tano, MD         
Idrottsmedicin Recruiting
Umeå, Sweden
Contact: Christer Malm, Associate professor       christer.malm@idrott.umu.se   
Principal Investigator: Christer Malm, Associate professor         
Sponsors and Collaborators
Umeå University
Investigators
Principal Investigator: Krister Tano, MD,PhD Umeå University
  More Information

No publications provided

Responsible Party: Krister Tano, MD, PhD, Umeå University
ClinicalTrials.gov Identifier: NCT01883453     History of Changes
Other Study ID Numbers: GOcoldU&B2013
Study First Received: April 23, 2013
Last Updated: June 24, 2013
Health Authority: Sweden: Regional Committee of Ethics

Additional relevant MeSH terms:
Common Cold
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 22, 2014