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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:
ClinicalTrials.gov Identifier:
NCT00259831
First Posted: December 1, 2005
Last Update Posted: June 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Capital Health, Canada
Information provided by:
Afexa Life Sciences Inc
  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
Intervention Model: Parallel Assignment
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00259831     History of Changes
Other Study ID Numbers: CVT-E002-2005-3
First Submitted: November 29, 2005
First Posted: December 1, 2005
Last Update Posted: June 8, 2009
Last Verified: June 2009

Keywords provided by Afexa Life Sciences Inc:
cold
influenza

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