Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247520
Status:
UNKNOWN
Last Update Posted:
2005-11-02
First Post:
2005-11-01
Brief Title:
Safety and Efficacy Study of rEV131 in Allergic Rhinitis
Sponsor:
Evolutec Group
Organization:
Evolutec Group
Study Overview
Official Title:
Two Center Evaluation of the Safety and Efficacy of Topical Nasal rEV131 Versus rEV131 Vehicle Placeboin the Prevention of the Signs and Symptoms of Allergic Rhinitis Induced by Nasal Allergen Challenge
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 063 125 25 and 50 mgml 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
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 063 125 25 and 50 mgml 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None