Full Text View
Tabular View
No Study Results Posted
Related Studies
Safety and Efficacy Study of rEV131 in Allergic Rhinitis
This study is ongoing, but not recruiting participants.
First Received: November 1, 2005   No Changes Posted
Sponsored by: Evolutec Group
Information provided by: Evolutec Group
ClinicalTrials.gov Identifier: NCT00247520
  Purpose

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.


Condition Intervention Phase
Hay Fever
Drug: topical nasal rEV131
Phase I
Phase II

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Evolutec Group:

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

Estimated Enrollment: 112
Study Start Date: May 2005
Estimated Study Completion Date: August 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

    1. Total symptom score of at least 6 OR
    2. ≥ 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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247520

Locations
United States, Texas
Sylvana Research Associates
San Antonio, Texas, United States, 78229
Diagnostics Research Group
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Evolutec Group
Investigators
Study Director: Wynne H Weston-Davies, MB FRCS Evolutec Group plc
  More Information

No publications provided

Study ID Numbers: EV-71-004
Study First Received: November 1, 2005
Last Updated: November 1, 2005
ClinicalTrials.gov Identifier: NCT00247520     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Evolutec Group:
Seasonal allergic rhinitis (SAR), rhinoconjunctivitis, allergy

Study placed in the following topic categories:
Fever
Signs and Symptoms
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Hypersensitivity
Otorhinolaryngologic Diseases
Respiratory Tract Infections
Immune System Diseases
Respiratory Tract Diseases
Rhinitis, Allergic, Seasonal
Hypersensitivity, Immediate
Rhinitis
Nose Diseases
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 10, 2009