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

NCT00726401 | Completed Phase 2

• 1 other identifier: CVT-E002-2007-2
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

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.

Conditions

Seasonal Allergic Rhinitis

Keywords

Allergies; Nasal; Congestion; Sneezing; Pruritus; Teary; Eyes

Outcome Measures

Primary Outcomes (1)

• Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms

  4 weeks

Secondary Outcomes (1)

• Safety and tolerability of CVT-E002

  4 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: COLD-fX

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

COLD-fX DRUG

200mg BID for 4 weeks

Also known as: CVT-E002

1

Placebo DRUG

200mg BID for 4 weeks

2

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Afexa Life Sciences Inc: lead

Study Sites (4)

Capital Health

Edmonton, Alberta, T5N 4A3, Canada

Location

McMaster University Medical Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Melimar Allergy Laboratory

Toronto, Ontario, M3H 3S3, Canada

Location

JDM Research

Toronto, Ontario, M4P 1P2, Canada

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity; Sneezing; Pruritus

Interventions

COLD-fX

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Skin Manifestations

Study Officials

• Gerald Predy, FFCPC

  Capital Health, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 29, 2008
• First Posted: July 31, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: October 11, 2010

Record last verified: 2010-10

Locations

CA (4)