Safety and Efficacy Study of rEV131 in Allergic Rhinitis
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ClinicalTrials.gov Identifier: NCT00247520 |
Recruitment Status : Unknown
Verified November 2005 by Evolutec Group.
Recruitment status was: Active, not recruiting
First Posted : November 2, 2005
Last Update Posted : November 2, 2005
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Tracking Information | ||||
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First Submitted Date ICMJE | November 1, 2005 | |||
First Posted Date ICMJE | November 2, 2005 | |||
Last Update Posted Date | November 2, 2005 | |||
Study Start Date ICMJE | May 2005 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures ICMJE |
Sum of symptom scores at 15 minutes post allergen challenge | |||
Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | No Changes Posted | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Safety and Efficacy Study of rEV131 in Allergic Rhinitis | |||
Official Title ICMJE | 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 | |||
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. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Prevention |
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Condition ICMJE | Hay Fever | |||
Intervention ICMJE | Drug: topical nasal rEV131 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Enrollment ICMJE |
112 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | August 2005 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00247520 | |||
Other Study ID Numbers ICMJE | EV-71-004 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Evolutec Group | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Evolutec Group | |||
Verification Date | November 2005 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |