- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00247520
Safety and Efficacy Study of rEV131 in Allergic Rhinitis
Two Center Evaluation of the Safety and Efficacy of Topical Nasal rEV131 Versus rEV131 Vehicle (Placebo)in the Prevention of the Signs and Symptoms of Allergic Rhinitis Induced by Nasal Allergen Challenge
Study Overview
Detailed Description
Hypothesis: rEV131, a histamine binding protein (derived from tick saliva) with an affinity for histamine 10 - 100 fold that of natural histamine receptors, might attenuate Nasal Allergen Challenge (NAC) induced allergic rhinitis.
Methods: Patients with known ragweed allergy will be screened to determine the minimal threshold concentration (PD30) of pollen extract that consistently induces the four key symptoms of allergic rhinitis: itch, sneezing, congestion and mucus production. A standardised system of TNSS scoring will be used. A total of 112 eligible patients will be randomised in double blind fashion to receive one of four concentrations of rEV131 (0.63, 1.25, 2.5 and 5.0 mg/ml) by nasal spray 30 minutes prior to NAC or placebo. Symptoms will be scored at 15, 30 and 45 minutes post NAC. Mean sum of symptom scores of all active medication treated patients will be compared with those of placebo treated patients. The primary analysis will be the sum of scores at 15 minutes post challenge for the optimum concentration of rEV131. Secondary outcome variables will include comparison of individual symptom and percentage of patients having a clinically significant response.
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
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San Antonio, Texas, United States, 78229
- Diagnostics Research Group
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San Antonio, Texas, United States, 78229
- Sylvana Research Associates
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
a) Have a known past history of allergic rhinitis including allergy to ragweed pollen.
b) Able and willing to give informed consent. c) Able and willing to follow all study related instructions. d) Able and willing to make all required visits. e) Aged between 18 and 80 years. f) Willing to avoid prohibited medications (see below). g) Has met at least one of the endpoints to allergen challenge at Visit 1
- Total symptom score of at least 6 OR
≥ 30% reduction in nasal volume in at least one side of the nose as measured by acoustic rhinometry AND total symptom score of at least 4.
h) Has met endpoint to allergen challenge at Visit 2: Total symptom score of at least 4 from a possible total of 12.
Exclusion Criteria:
a) Patients with known exaggerated immuogenicity responses including severe asthma or peanut allergy.
b) Patients with known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
c) Patients with known chronic sinusitis, deviated nasal septum or nasal polyposis.
d) Patients having a total Baseline symptom score of >4 at Visit 1 (ie before the first nasal washout).
e) Patients known or found to be allergic to pollens prevalent in the trial site locality during the period of the study (e.g. mountain cedar).
f) Patients who have taken systemic or topical corticosteroids, long acting antihistamines or immunosuppressives within 4 weeks of selection (V1) or who take them within the course of the trial. Loratidine may not be taken within 10 days of entry. Short acting antihistamines may not be taken within 72 hours of entry except as comfort medication following nasal allergen challenge (oral antihistamines only). Patients excluded from the study for non-compliance with regard to prohibited medications but who have received one or more doses of the test medications will be included in the safety analysis.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Sum of symptom scores at 15 minutes post allergen challenge
|
Secondary Outcome Measures
Outcome Measure |
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Sum of symptom scores at 30 and 45 minutes post allergen challenge
|
Individual symptom scores at 15, 30 and 45 minutes post challenge
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Pre and post treatment responder analysis
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Change in nasal volume as assessed by acoustic rhinometry
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wynne H Weston-Davies, MB FRCS, Evolutec Group plc
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EV-71-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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