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

Upper Respiratory Infection Clinical Trial

Official title:

Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adult Employees in Continuing Care Facilities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259831
• Other study ID #: CVT-E002-2005-3
• Status: Completed
• Phase: Phase 3
• First received: November 29, 2005
• Last updated: June 4, 2009
• Start date: December 2005
• Est. completion date: August 2006

Study information

• Verified date: June 2009
• Source: Afexa Life Sciences Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: August 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Respiratory Tract Infections
• Upper Respiratory Infection

Intervention

Drug:
• CVT-E002 (Cold-FX); a natural health product

Locations

Country	Name	City	State
Canada	The Capital Care Group Continuing Care facilities	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
CV Technologies	Capital Health, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study.
Secondary	To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection.