Seasonal Allergic RhinitisPhase 2NCT00726401
A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
A Phase 2 study testing COLD-fX in people with Seasonal Allergic Rhinitis, run by Afexa Life Sciences Inc at 4 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 12 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Allergic Rhinitis
- What is being tested?
- COLD-fX
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesCanada
- Study dates
- May 2008to Sep 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Medical conditions:
- Perennial rhinitis with little or no seasonal flare-ups
- Rhinitis medicamentosa
- Non-allergic rhinitis
- Nasal polyps
- Severe asthma that is poorly controlled
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- 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
Trial locations and contacts
4 sites in 1 country.
Canada4 sites
Capital Health
Edmonton, Alberta, T5N 4A3
McMaster University Medical Centre
Hamilton, Ontario, L8N 3Z5
Melimar Allergy Laboratory
Toronto, Ontario, M3H 3S3
JDM Research
Toronto, Ontario, M4P 1P2
About this study
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.
Read the 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.
- Conditions
- Seasonal Allergic Rhinitis
- Being tested
- COLD-fX, Placebo
- Keywords
- Allergies, Nasal, Congestion, Sneezing, Pruritus, Teary, Eyes
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity, Sneezing, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COLD-fXDrug
Also called CVT-E002
200mg BID for 4 weeks
PlaceboDrug
200mg BID for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: COLD-fX |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms
Measured: 4 weeks
Secondary outcomes (1)
Safety and tolerability of CVT-E002
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2008 (estimated)
- Study startMay 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Afexa Life Sciences Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gerald Predy, FFCPC, Principal investigator, Capital Health, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00726401
- Sponsor's protocol ID
- CVT-E002-2007-2
- Status last verified
- Oct 2010
- First submitted
- 29 Jul 2008
- Last updated
- 11 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Study on the Effect of CVT-E002 in Patients With Seasonal Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT00726401
- Acronym / sponsor ID
- CVT-E002-2007-2
- Conditions
- Seasonal Allergic Rhinitis
- Keywords
- Allergies, Nasal, Congestion, Sneezing, Pruritus, Teary, Eyes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Afexa Life Sciences IncIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 31 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: COLD-fX |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (39 listed)
- Medical conditions:
- Medications:
- Daily smokers (> 25 cigarettes per day)
- History of alcohol/drug abuse
- Suspected substance abuse or dependence active within the preceding 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COLD-fXAlso: CVT-E002200mg BID for 4 weeks | Drug | 1 |
| Placebo200mg BID for 4 weeks | Drug | 2 |
Primary outcome
Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms
Time frame: 4 weeks
1 secondary outcome
Safety and tolerability of CVT-E002
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Predy, FFCPC principal investigator
Capital Health, Canada
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing COLD-fX in people with Seasonal Allergic Rhinitis, run by Afexa Life Sciences Inc at 4 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary estimates of treatment effect of CVT-E002 in improving quality of life and reducing symptoms (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2010; AzTrials last refreshed its copy on 28 Oct 2026.