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

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. Identifier: NCT00726401
Recruitment Status : Completed
First Posted : July 31, 2008
Last Update Posted : October 11, 2010
Information provided by:
Afexa Life Sciences Inc

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Drug: COLD-fX Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
Study Start Date : May 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hay Fever

Arm Intervention/treatment
Active Comparator: 1 Drug: COLD-fX
200mg BID for 4 weeks
Other Name: CVT-E002

Placebo Comparator: 2 Drug: Placebo
200mg BID for 4 weeks

Primary Outcome Measures :
  1. Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Safety and tolerability of CVT-E002 [ Time Frame: 4 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00726401

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Canada, Alberta
Capital Health
Edmonton, Alberta, Canada, T5N 4A3
Canada, Ontario
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
Melimar Allergy Laboratory
Toronto, Ontario, Canada, M3H 3S3
JDM Research
Toronto, Ontario, Canada, M4P 1P2
Sponsors and Collaborators
Afexa Life Sciences Inc
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Principal Investigator: Gerald Predy, FFCPC Capital Health, Canada
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Responsible Party: Dr. Jacqueline Shan, Afexa Life Sciences Identifier: NCT00726401    
Other Study ID Numbers: CVT-E002-2007-2
First Posted: July 31, 2008    Key Record Dates
Last Update Posted: October 11, 2010
Last Verified: October 2010
Keywords provided by Afexa Life Sciences Inc:
Additional relevant MeSH terms:
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Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases