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

Seasonal Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00726401
• Other study ID #: CVT-E002-2007-2
• Status: Completed
• Phase: Phase 2
• First received: July 29, 2008
• Last updated: October 7, 2010
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: October 2010
• Source: Afexa Life Sciences Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rhinitis
• Rhinitis, Allergic, Seasonal
• Seasonal Allergic Rhinitis

Intervention

Drug:
• COLD-fX
200mg BID for 4 weeks
• Placebo
200mg BID for 4 weeks

Locations

Country	Name	City	State
Canada	Capital Health	Edmonton	Alberta
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	JDM Research	Toronto	Ontario
Canada	Melimar Allergy Laboratory	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Afexa Life Sciences Inc

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms		4 weeks	No
Secondary	Safety and tolerability of CVT-E002		4 weeks	Yes