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

• Sponsor: CV Technologies (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00259831
• Collaborator: Capital Health, Canada (Other)
• Enrollment: 500
• Location: 1
• Duration (Months): 8
• Patients Per Site Per Month: 62.6

Study Details

Study Description

Brief 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.

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

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.

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Jun 1, 2006
• Actual Study Completion Date: Aug 1, 2006

Outcome Measures

Primary Outcome Measures

1. To determine the efficacy of CVT-E002 in reducing the number of upper respiratory infections during the study. []

Secondary Outcome Measures

1. To test if the prophylactic management with CVT-E002 decreases the severity and duration of symptoms related to an upper respiratory tract infection. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00259831
• Other Study ID Numbers: CVT-E002-2005-3
• First Posted: Dec 1, 2005
• Last Update Posted: Jun 8, 2009
• Last Verified: Jun 1, 2009

• Keywords provided by , ,: cold; influenza
• Additional relevant MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections

Study Results

No Results Posted as of Jun 8, 2009