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

NCT01883453 | Completed Phase 2 Results DMC

• 1 other identifier: GOcoldU&B2013
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Common Cold

Outcome Measures

Primary Outcomes (1)

• Reducing Symptoms of a Common Cold

  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. WURSS 21 is a validated tool of calculating the degree of common Cold symptoms. It consists of 21 questions (20 questions are possible to evaluate) which are graded from 0 to 7 (worst degree of symptoms). These 20 questions (sum of all symptoms) are evaluated every day, Min value is thus 0 and max value/person/day is 140. It is thus possible to calculate the mean value of sum of symptoms for each day in the both groups.

  One week

Study Arms (2)

Saline+glucose nasal spray

PLACEBO COMPARATOR

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

Device: Saline+5%glucose

Nasal spray with glucose oxidase+glucose

ACTIVE COMPARATOR

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.

Device: Glucose oxidase+5%glucose

Interventions

Glucose oxidase+5%glucose DEVICE

A hydrogen peroxide producing enzyme

Nasal spray with glucose oxidase+glucose

Saline+5%glucose DEVICE

Isotonic saline + 5% glucose in a bag-on-valve nasal spray device

Saline+glucose nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults

You may not qualify if:

• Ongoing allergy

Sponsors & Collaborators

• Umeå University: lead

Study Sites (2)

Försvarshälsan

Boden, Sweden

Location

Idrottsmedicin

Umeå, Sweden

Location

MeSH Terms

Conditions

Common Cold

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

Too few virus positive persons in order to get significant results. Local side effects were mild and about the same as in the placebo Group. Influensa season and few rhinovirus infections.

Results Point of Contact

• Title: Dr Krister Tano
• Organization: Umeå University

krister.tano@umu.se

0046705569043

Study Officials

• Krister Tano, MD,PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: June 21, 2013
• Study Start: January 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 9, 2015
• Results First Posted: November 9, 2015

Record last verified: 2015-06

Locations

SE (2)