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Safety and Efficacy Study of rEV131 in Allergic Rhinitis

Primary Purpose

Hay Fever

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
topical nasal rEV131
Sponsored by
Evolutec Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hay Fever focused on measuring Seasonal allergic rhinitis (SAR), rhinoconjunctivitis, allergy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Diagnostics Research Group
  • Sylvana Research Associates

Outcomes

Primary Outcome Measures

Sum of symptom scores at 15 minutes post allergen challenge

Secondary Outcome Measures

Sum of symptom scores at 30 and 45 minutes post allergen challenge
Individual symptom scores at 15, 30 and 45 minutes post challenge
Pre and post treatment responder analysis
Change in nasal volume as assessed by acoustic rhinometry

Full Information

First Posted
November 1, 2005
Last Updated
November 1, 2005
Sponsor
Evolutec Group
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1. Study Identification

Unique Protocol Identification Number
NCT00247520
Brief Title
Safety and Efficacy Study of rEV131 in Allergic Rhinitis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
November 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Evolutec Group

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see whether rEV131 when given as a nasal spray in a single dose to each nostril is safe and can reduce the signs and symptoms of allergic rhinitis (hay fever) caused by an allergen challenge. All patients enrolled will be known to be allergic to ragweed pollen and will be given ragweed pollen extract in both nostrils 30 minutes after either rEV131 or innactive vehicle (placebo). The signs and symptoms (sneezing, itching, stuffiness and runny nose) will each be given a score from 0 to 3 by the patient and these will be added together and the combined scores from patients treated with rEV131 will be compared with those who received placebo.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hay Fever
Keywords
Seasonal allergic rhinitis (SAR), rhinoconjunctivitis, allergy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
112 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
topical nasal rEV131
Primary Outcome Measure Information:
Title
Sum of symptom scores at 15 minutes post allergen challenge
Secondary Outcome Measure Information:
Title
Sum of symptom scores at 30 and 45 minutes post allergen challenge
Title
Individual symptom scores at 15, 30 and 45 minutes post challenge
Title
Pre and post treatment responder analysis
Title
Change in nasal volume as assessed by acoustic rhinometry

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wynne H Weston-Davies, MB FRCS
Organizational Affiliation
Evolutec Group plc
Official's Role
Study Director
Facility Information:
Facility Name
Diagnostics Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

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Safety and Efficacy Study of rEV131 in Allergic Rhinitis

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