Grass pollen allergy
Conditions
Interventions
Product Name: BM32
Pharmaceutical Form: Suspension for injection
Other descriptive name: BM322
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 0,05-
P
Sponsors
Medizinische Universität Wien, HNO Klinik
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 o Depot corticosteroids – 12 weeks prior to screening of study CS-BM32-003 o Oral corticosteroids – 8 weeks prior to screening visit o High-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo, on allergen-specific Ig levels in nasal secretion during 2 consecutive treatment years. ;Secondary Objective: • To evaluate if changes in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo are associated with changes in serum Ig levels • To evaluate if changes in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo are associated with changes in recorded Symptom-Score (SS) and Medication-Score (MS) • To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the presence of immune cells in nasal secretions • To evaluate the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the cytokine pattern in nasal secretions ;Primary end point(s): Changes on allergen-specific Ig levels in nasal secretions;Timepoint(s) of evaluation of this end point: Treatment year one: • Visit 1: before the 1st pre-seasonal vaccination • Visit 2: after the 3rd pre-seasonal vaccination • Visit 3: in the middle of the grasspollen season • Visit 4: 2 weeks after the end of the grass pollen season Treatment year two: • Visit 5: before the 1st pre-seasonal vaccination (5th vaccination) • Visit 6: after the 3rd pre-seasonal vaccination (7th vaccination) • Visit 7: in the middle of the grasspollen season • Visit 8: 2 weeks after the end of the grass pollen season | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Association of changes in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo with changes in serum Ig levels • Association of canges in Ig levels in nasal secretion upon immunotherapy with the hypoallergenic vaccine BM32 or placebo with changes in recorded Symptom-Score (SS) and Medication-Score (MS) • Association of the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the presence of immune cells in nasal secretions • Association of the effect of immunotherapy with the recombinant hypoallergenic vaccine, BM32, compared to placebo on the cytokine pattern in nasal secretions ;Timepoint(s) of evaluation of this end point: Treatment year one: • Visit 1: before the 1st pre-seasonal vaccination • Visit 2: after the 3rd pre-seasonal vaccination • Visit 3: in the middle of the grasspollen season • Visit 4: 2 weeks after the end of the grass pollen season Treatment year two: • Visit 5: before the 1st pre-seasonal vaccination (5th vaccination) • Visit 6: after the 3rd pre-seasonal vaccination (7th vaccination) • Visit 7: in the middle of the grasspollen season • Visit 8: 2 weeks after the end of the grass pollen season | — |
Countries
Austria
Contacts
Public ContactHNO Klinik
Medizinische Universität Wien
Outcome results
None listed