A Randomized, Double-Blind, Placebo-Controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
Information source: CV Technologies
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Seasonal Allergic Rhinitis
Intervention: COLD-fX (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: CV Technologies Official(s) and/or principal investigator(s):
Gerald Predy, FFCPC, Principal Investigator, Affiliation: Capital Health, Canada
Overall contact:
Elizabeth Chomin, RN, Phone: 7809045747
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.
Clinical Details
Official title: A Randomized, Double-Blind, Placebo-Controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms
Secondary outcome: Safety and tolerability of CVT-E002
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
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
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
Locations and Contacts
Elizabeth Chomin, RN, Phone: 7809045747
Capital Health, Edmonton, Alberta T5N 4A3, Canada; Recruiting
Gerald Predy, FRCPC, Principal Investigator
Additional Information
Starting date: May 2008
Ending date: January 2010
Last updated: January 8, 2009
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