Study on the effect of BM32, a vaccine for immunotherapy of grass pollen allergy, on immunoglobulin levels in nasal secretions

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

• Registration Number: EUCTR2012-004194-12-AT
• Lead Sponsor: Medizinische Universität Wien, HNO Klinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-08
• Last Update Posted: 8 December 2014

Recruitment & Eligibility

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

Inclusion Criteria

•Positive history of grass pollen allergy, positive skin prick test reaction to grass pollen extract, grass pollen allergen-specific IgE and rPhl p 1/rPhl p 5-specific IgE (at least 3.5 kUA/L) at the screening visit of CS-BM32-003 or within 12 months prior to the screening visit of CS-BM32-003
•Moderate to severe symptoms of grass pollen allergy during pollen peak in the baseline period of CS-BM32-003
•Age between 18 and 60 years (m/f)
•Subjects must have a standard health care insurance
•Subjects must appear capable to understand and comply with all relevant aspects of the study protocol
•Subject must be available during the study period to complete all treatments and assessments
•Participation in the study CS-BM32-003 (EK 1104/2012)
•Willingness to comply with the study protocol and written informed consent

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 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Symptomatic perennial allergies
•Atopic dermatitis
•Pregnangy or breast feeding
•Women with childbearing potential who are not using a medically accepted birth control method
•Autoimmune diseases, immune defects including immuno-suppression, immune-complex-induced immunopathies
•Contra-indication for adrenaline
•Severe general maladies, malignant disease
•Patients under long-term treatment with systemic corticosteroids, immunosuppressive drugs, tranquilizers or psychoactive drugs
•Contra-indications for skin prick testing such as: skin inflammation in the test area, urticaria factitia
•Asthma not controlled by low dose corticosteroids
•Chronic use of beta-blockers
•Participation in a pollen SIT trial in 2 years prior to the study
•Patients who had a previous grass pollen SIT
•Risk of non-compliance with the study procedure and restricitions
•Use of prohibited medication prior to screening of study CS-BM32-003 and throughout the study
oDepot corticosteroids – 12 weeks prior to screening of study CS-BM32-003
oOral corticosteroids – 8 weeks prior to screening visit
oHigh-dose inhaled corticosteroids – 4 weeks prior to screening
•Use of anti-histamines three days prior to the visits where a skin prick test is performed

Study & Design

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