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Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults

This study has been completed.
Sponsor:
Collaborator:
Capital Health, Canada
Information provided by:
Afexa Life Sciences Inc
ClinicalTrials.gov Identifier:
NCT00259831
First received: November 29, 2005
Last updated: June 4, 2009
Last verified: June 2009
  Purpose

The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for upper respiratory tract infections in healthy adult employees working with residents in continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively reduce the incidence, severity and duration of upper respiratory infections among the participants when compared to placebo.


Condition Intervention Phase
Upper Respiratory Infection
Drug: CVT-E002 (Cold-FX); a natural health product
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adult Employees in Continuing Care Facilities

Further study details as provided by Afexa Life Sciences Inc:

Primary Outcome Measures:
  • To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.

Secondary Outcome Measures:
  • To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.

Estimated Enrollment: 500
Study Start Date: December 2005
Study Completion Date: August 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Eligible continuing care employees will be randomly assigned to either the treatment or placebo group with equal numbers in each group. The treatment will consist of taking two capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12 weeks. The subjects will be given an assessment form to log specific symptoms on a daily basis if they get a cold.

Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and fever. Subjects will be required to maintain the same dosing even during an upper respiratory infection and will be requested not to take any additional medication for their upper respiratory infection unless prescribed by their family physicians.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 18-64 years
  • not pregnant or breast feeding
  • good general health

Exclusion Criteria:

  • medical conditions: HIV infection; malignancy; cardiovascular disease; hypertension; renal, pulmonary or hepatic abnormalities; neurologic or psychiatric disease; tuberculosis; multiple sclerosis; recent acute respiratory infection (<2 weeks)
  • medications: warfarin; immunosuppressive therapy; corticosteroids; phenalzine; pentobarbital; haloperidol
  • major surgical procedure in the previous six months
  • history of alcohol/drug abuse
  • pregnancy and lactation in women
  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: NCT00259831

Locations
Canada, Alberta
The Capital Care Group Continuing Care facilities
Edmonton, Alberta, Canada, T5K 2J8
Sponsors and Collaborators
CV Technologies
Capital Health, Canada
Investigators
Principal Investigator: Gerry Predy, MD Capital Health, Canada
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00259831     History of Changes
Other Study ID Numbers: CVT-E002-2005-3
Study First Received: November 29, 2005
Last Updated: June 4, 2009
Health Authority: Canada: Health Canada

Keywords provided by Afexa Life Sciences Inc:
cold
influenza

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014