Safety and dose finding study of BM32 in subjects suffering from grass pollen allergy

• Conditions: Grass pollen allergy; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2011-003368-64-AT
• Lead Sponsor: Biomay AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-16
• Last Update Posted: 29 May 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

?The subject is allergic but otherwise healthy. Healthy subjects are defined as individuals who are free from clinically significant illness or disease as determined by their medical history (including family), physical examination, laboratory studies, and other tests deemed by the Investigator or designee.
?Male or female between 18 and 60 years of age inclusive, at the time of signing the informed consent. They have a history of seasonal allergic rhinitis (SAR) to grass pollen.
?They have a normal electrocardiogram without clinically significant abnormalities deemed by the Investigator or designee.
?They exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 after the first 2h in the Vienna Challenge Chamber, which is defined as a nasal symptom Score (TNSS) of at least 6. (Nasal symptom Score is the sum of nasal obstruction, rhinorrhoea, itchy nose and sneezing, each of which have been Scored on a scale from 0 to 3).
?They have a positive skin prick test (wheal diameter ? 3mm) for grass pollen at or within 12 months preceding the screening visit.
?They have a positive RAST (class greater/equal 2) for timothy grass pollen (g6) and to rPhl p 1+rPhl p 5 at or within 12 months preceding the screening visit.
?There are no conditions or factors which would make the subject unlikely to be able to stay in the chamber for 6 hours.
?They are capable of giving informed consent which includes compliance with the requirements and restrictions listed in the consent form.
?They are available to complete all study measurements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 72
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

?Pregnant, lactating or sexually active women with childbearing potential who are not using a medically accepted birth control method (pregnancy to be controlled by a pregnancy dipstick test).
?On examination the subject is found to have any structural nasal abnormalities or nasal polyposis, a history of frequent nosebleeds, recent nasal surgery or ongoing upper respiratory tract infection which in the Responsible Physician’s opinion renders the subject unsuitable for participation in the study.
?Any respiratory disease other than mild stable asthma that is controlled with occasional use of as-needed short-acting beta-agonists and associated with normal lung function.
?The subject is concurrently participating or has participated in any clinical study in the previous month.
?The subject has received SIT for grass pollen allergy in the last two years prior to this study.
?Past or present disease, which as judged by the investigator, may affect the outcome of this study.

?autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies
?Suspected hypersensitivity to any ingredients of the study medication
?Use of prohibited medication prior to Screening and throughout the study:
oDepot corticosteroids – 12 weeks
oOral corticosteroids – 8 weeks
oInhaled corticosteroids – 4 weeks
?The subject is at risk of non-compliance with the study procedures/restrictions.
?Allergic symptoms at the time of screening
?Any other reason that the Investigator considers makes the subject unsuitable to participate.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified