Status:
COMPLETED
A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
Lead Sponsor:
Afexa Life Sciences Inc
Conditions:
Seasonal Allergic Rhinitis
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
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 ben...
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 Criteria
Inclusion
- Healthy individuals of both genders aged 12 - 75 years
- 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
- Determined by the investigators that well-controlled mild to moderate asthmatics will not be excluded
- Daytime nasal symptoms of at least mild-to-moderate severity (cumulative score of at least 42 over a 7-day run-in period)
- 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)
- Willing to adhere to the requirements of the protocol, including availability for follow-up visits
- Willing and able to sign written informed consent
Exclusion
- 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
- 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.)
- Daily smokers (\> 25 cigarettes per day)
- History of alcohol/drug abuse
- Suspected substance abuse or dependence active within the preceding 4 weeks
- Pregnant or breast-feeding women
- Allergy to ginseng, microcrystalline cellulose, or gelatin
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00726401
Start Date
May 1 2008
End Date
September 1 2010
Last Update
October 11 2010
Active Locations (4)
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1
Capital Health
Edmonton, Alberta, Canada, T5N 4A3
2
McMaster University Medical Centre
Hamilton, Ontario, Canada, L8N 3Z5
3
Melimar Allergy Laboratory
Toronto, Ontario, Canada, M3H 3S3
4
JDM Research
Toronto, Ontario, Canada, M4P 1P2