Safety and Efficacy Study of rEV131 in Allergic Rhinitis

NCT00247520 | Unknown Phase 1

• 1 other identifier: EV-71-004
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 2

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.

Conditions

Hay Fever

Keywords

Seasonal allergic rhinitis (SAR), rhinoconjunctivitis, allergy

Outcome Measures

Primary Outcomes (1)

• Sum of symptom scores at 15 minutes post allergen challenge

Secondary Outcomes (4)

• 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

Interventions

topical nasal rEV131 DRUG

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Evolutec Group: lead

Study Sites (2)

Diagnostics Research Group

San Antonio, Texas, 78229, United States

Location

Sylvana Research Associates

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal; Hypersensitivity

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Wynne H Weston-Davies, MB FRCS

  Evolutec Group plc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 1, 2005
• First Posted: November 2, 2005
• Study Start: May 1, 2005
• Study Completion: August 1, 2005
• Last Updated: November 2, 2005

Record last verified: 2005-11

Locations

US (2)