A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis

You are being asked to take part in a research study of COLD-fX, a product designed to boost the immune system. COLD-fX is an extract from the roots of North American ginseng and it may offer some benefit to people with seasonal allergies.

The purpose of the present study is to find out how effective and safe COLD-fX is in improving quality of life and reducing symptoms of seasonal allergies such as hay fever. COLD-fX is not yet approved for treatment of seasonal allergies. We are seeking to enroll 200 participants in the Capital Health region.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: COLD-fX; Drug: Placebo

Detailed Description

A randomized, double-blind, placebo-controlled study will be carried out to establish the effects of CVT-E002 200 mg twice daily for 4 weeks in patients with seasonal allergic rhinitis.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T5N 4A3
      • Capital Health
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster University Medical Centre
    • Toronto, Ontario, Canada, M3H 3S3
      • Melimar Allergy Laboratory
    • Toronto, Ontario, Canada, M4P 1P2
      • JDM Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 75 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy individuals of both genders aged 12 - 75 years
2. Documented clinical history of seasonal allergic rhinitis for at least 2 years with exacerbations during the study season; and exhibit a positive skin-prick test (wheal diameter at least 3 mm greater than saline control) to one of the regional allergens active during the study season
3. Determined by the investigators that well-controlled mild to moderate asthmatics will not be excluded
4. Daytime nasal symptoms of at least mild-to-moderate severity (cumulative score of at least 42 over a 7-day run-in period)
5. Women of child bearing capacity who agree to use an acceptable form of birth control during the trial (i.e., oral contraception, reliable use of a double-barrier method (e.g., condom and diaphragm, condom and foam, condom and sponge), IUD, or tubal ligation)
6. Willing to adhere to the requirements of the protocol, including availability for follow-up visits
7. Willing and able to sign written informed consent

Exclusion Criteria:

1. Medical conditions:

   • Perennial rhinitis with little or no seasonal flare-ups
   • Rhinitis medicamentosa
   • Non-allergic rhinitis
   • Nasal polyps
   • Severe asthma that is poorly controlled
   • Active tuberculosis
   • Cystic fibrosis
   • Upper respiratory tract infection within the preceding 4 weeks
   • Significant other pulmonary disorders
   • Any ongoing allergen immunotherapy during study or for 6 months prior
   • HIV/AIDS
   • Malignancy (under active observation or treatment)
   • Unstable cardiovascular disease (physician visit or hospitalization for unstable cardiovascular disease in the last 6 months)
   • Renal abnormalities (serum creatinine known to be > 200 mmol/l)
   • Acute or active chronic liver disease
   • Diabetes
   • Neurological or psychiatric disease (progressive or currently under treatment)
   • Bleeding disorders
   • Major surgery in the last 6 months or planned surgery over the course of the study
   • Other serious medical conditions

2. Medications:

   • Medications for allergic rhinitis/conjunctivitis, including: antihistamines; oral, parenteral, nasal, and ophthalmic corticosteroids; cromolyn sodium; nedocromil; and intranasal anticholinergics (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.)
   • Oral or long-acting b-agonists, theophylline, and leukotriene modifiers
   • Medications that can affect nasal or ocular symptoms, including decongestants and anti-inflammatory drugs
   • Allergic rhinitis rescue medications
   • Use of immunosuppressants
   • Hormone replacement therapy
   • Phenelzine
   • Pentobarbital
   • Haloperidol
   • Warfarin
   • Heparin
   • Any other natural health products or dietary supplements, with the exception of vitamins and minerals with dose of > 600 mg/day of vitamin E and containing no vitamin K. Natural health products or dietary supplements include products such as, but not limited to, Echinacea, Ginseng (beverages, foods, extracts, capsules, or tablets), St. John's Wort, Gingko, Glucosamine, Fish Oil supplements, Evening Primrose Oil, Green Tea or other herbal products consumed in the form of a pill or capsule. (If the participants agree to stop taking these products prior to study entry and for the duration of the study, they can participate in the study.)
3. Daily smokers (> 25 cigarettes per day)
4. History of alcohol/drug abuse
5. Suspected substance abuse or dependence active within the preceding 4 weeks
6. Pregnant or breast-feeding women
7. Allergy to ginseng, microcrystalline cellulose, or gelatin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: 2	Drug: Placebo; 200mg BID for 4 weeks
ACTIVE_COMPARATOR: 1	Drug: COLD-fX; 200mg BID for 4 weeks; Other Names: CVT-E002

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms	4 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of CVT-E002	4 weeks

Collaborators and Investigators

• Sponsor: Afexa Life Sciences Inc
• Investigators: Principal Investigator: Gerald Predy, FFCPC, Capital Health, Canada

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (ACTUAL): September 1, 2010
• Study Completion (ACTUAL): September 1, 2010

Study Registration Dates

• First Submitted: July 29, 2008
• First Submitted That Met QC Criteria: July 30, 2008
• First Posted (ESTIMATE): July 31, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): October 11, 2010
• Last Update Submitted That Met QC Criteria: October 7, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Sneezing; Pruritus; Congestion; Nasal; Allergies; Eyes; Teary
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: CVT-E002-2007-2