Hay FeverPhase 1/2NCT00247520
Safety and Efficacy Study of rEV131 in Allergic Rhinitis
A Phase 1/2 study testing topical nasal rEV131 in people with Hay Fever, run by Evolutec Group at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hay Fever
- What is being tested?
- topical nasal rEV131
- How many people
- 112 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2005to Aug 2005
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- a) Have a known past history of allergic rhinitis including allergy to ragweed pollen.
- 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.
- Has met endpoint to allergen challenge at Visit 2: Total symptom score of at least 4 from a possible total of 12.
Who cannot join
- a) Patients with known exaggerated immuogenicity responses including severe asthma or peanut allergy.
- Patients with known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
- Patients with known chronic sinusitis, deviated nasal septum or nasal polyposis.
- Patients having a total Baseline symptom score of >4 at Visit 1 (ie before the first nasal washout).
- 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).
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Diagnostics Research Group
San Antonio, Texas, 78229
Sylvana Research Associates
San Antonio, Texas, 78229
About this 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
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.
Read the 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.
- Conditions
- Hay Fever
- Being tested
- topical nasal rEV131
- Keywords
- Seasonal allergic rhinitis (SAR), rhinoconjunctivitis, allergy
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical nasal rEV131Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2005 (estimated)
- Study startMay 2005
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hay FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 112 participants
Sponsor and investigators
- Lead sponsor
- Evolutec Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wynne H Weston-Davies, MB FRCS, Study director, Evolutec Group plc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247520
- Sponsor's protocol ID
- EV-71-004
- Status last verified
- Nov 2005
- First submitted
- 1 Nov 2005
- Last updated
- 2 Nov 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00247520
- Acronym / sponsor ID
- EV-71-004
- Conditions
- Hay Fever
- Keywords
- Seasonal allergic rhinitis (SAR), rhinoconjunctivitis, allergy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 112 participants
- Lead sponsor
- Evolutec GroupIndustry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Aug 2005
- First posted
- 2 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- a) Have a known past history of allergic rhinitis including allergy to ragweed pollen.
Key exclusion criteria (6 listed)
- a) Patients with known exaggerated immuogenicity responses including severe asthma or peanut allergy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical nasal rEV131 | Drug | – |
Primary outcome
Sum of symptom scores at 15 minutes post allergen challenge
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wynne H Weston-Davies, MB FRCS study director
Evolutec Group plc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing topical nasal rEV131 in people with Hay Fever, run by Evolutec Group at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of symptom scores at 15 minutes post allergen challenge. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2005.