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

This study has been completed.
Sponsor:
Information provided by:
Afexa Life Sciences Inc
ClinicalTrials.gov Identifier:
NCT00726401
First received: July 29, 2008
Last updated: October 7, 2010
Last verified: October 2010
  Purpose

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 Intervention Phase
Seasonal Allergic Rhinitis
Drug: COLD-fX
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Afexa Life Sciences Inc:

Primary Outcome Measures:
  • Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability of CVT-E002 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: May 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00726401

Locations
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
Investigators
Principal Investigator: Gerald Predy, FFCPC Capital Health, Canada
  More Information

No publications provided

Responsible Party: Dr. Jacqueline Shan, Afexa Life Sciences
ClinicalTrials.gov Identifier: NCT00726401     History of Changes
Other Study ID Numbers: CVT-E002-2007-2
Study First Received: July 29, 2008
Last Updated: October 7, 2010
Health Authority: Canada: Health Canada

Keywords provided by Afexa Life Sciences Inc:
Allergies
Nasal
Congestion
Sneezing
Pruritus
Teary
Eyes

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Rhinitis, Allergic, Perennial
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 20, 2014