Hay Fever Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
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