Status:
COMPLETED
Safety and Dose Finding Trial of BM32 in Subjects Suffering From Grass Pollen Allergy
Lead Sponsor:
Biomay AG
Conditions:
Grass Pollen Allergy
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief Summary
The study will evaluate the dose response of immunotherapy against grass pollen allergy using the recombinant grass pollen vaccine BM32. Efficacy will be analyzed by: * skin prick testing * grass pol...
Eligibility Criteria
Inclusion
- History of seasonal allergic rhinitis from grass pollen
- Normal electrocardiogram
- Moderate to severe response to approx. 1500 grass pollen grains/m3 after 2 hrs of exposure in challenge chamber
- Positive skin prick test for grass pollen at or within 12 months preceding screening visit
- Positive RAST (class 2 or higher) for timothy grass pollen and to rPhl p 1 + rPhl p 5 at or within 12 months preceding screening visit
Exclusion
- Pregnant or lactating females
- Females with childbearing potential not using medically acceptable birth control
- Structural nasal abnormalities, nasal polyposis, history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection
- Any respiratory disease other than mild asthma controlled with occasional short acting beta agonists and normal lung function
- Current or recent participation in another clinical trial
- SIT for grass pollen allergy in the last two years prior to study
- Past or present disease, which may affect outcome of the trial, judged by investigator
- Autoimmune diseases, immune defects including immunosuppression, immune- complex immunopathies
- Suspected hypersensitivity to any ingredients of study medication
- Use of prohibited medication prior to screening and throughout study
- depot corticosteroids (12 weeks)
- oral corticosteroids (8 weeks)
- inhaled corticosteroids (4 weeks)
- Allergic symptoms at the time of screening
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01445002
Start Date
October 1 2011
End Date
October 1 2012
Last Update
January 14 2013
Active Locations (1)
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1
Allergy Center Vienna West
Vienna, Vienna, Austria, 1150