Last updated: November 1, 2005
Sponsor: Evolutec Group
Overall Status: Trial Status Unknown
Phase
1/2
Condition
Acute Rhinitis
Common Cold
Allergy
Treatment
N/AClinical Study ID
NCT00247520
EV-71-004
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 studyrelated 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 atleast 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 byacoustic rhinometry AND total symptom score of at least 4. h) Has met endpoint to allergen challenge at Visit 2: Total symptom score of atleast 4 from a possible total of 12.
Exclusion
Exclusion Criteria:
- a) Patients with known exaggerated immuogenicity responses including severe asthma orpeanut 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 thefirst nasal washout). e) Patients known or found to be allergic to pollens prevalent in the trial sitelocality during the period of the study (e.g. mountain cedar). f) Patients who have taken systemic or topical corticosteroids, long actingantihistamines or immunosuppressives within 4 weeks of selection (V1) or who take themwithin 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 ascomfort medication following nasal allergen challenge (oral antihistamines only).Patients excluded from the study for non-compliance with regard to prohibitedmedications but who have received one or more doses of the test medications will beincluded in the safety analysis.
Study Design
Total Participants: 112
Study Start date:
May 01, 2005
Estimated Completion Date:
August 31, 2005
Study Description
Connect with a study center
Diagnostics Research Group
San Antonio, Texas 78229
United StatesSite Not Available
Sylvana Research Associates
San Antonio, Texas 78229
United StatesSite Not Available

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