allergic rhinitis birchpollen allergy
Conditions
Interventions
SCIT treatment will be administered in a blinded double-dummy design as two
separate subcutaneous injections (one BM41/Placebo 1, one VD3/Placebo 2) within
1 cm of each other to ensure that subcutan
allergic rhinitis/ rhinoconjunctivitis
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent 2. Age *18 * 65 years 3. Moderate to severe birch-pollen-induced AR/ARC of at least 2 years according to the Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines (Appendix 1, see manual) with or without concomitant mild to moderate persistent asthma 4. FEV1>70% for patients with a history of asthma, FEV1>70% or PEF>80% for patients without a history of asthma 5. A positive SPT (mean wheal diameter * 3mm compared to negative control and negative control should be negative) for birch pollen assessed within 1 year before randomization 6. A positive TNPT for birch pollen at screening (Lebel score *6)
Exclusion criteria
Exclusion criteria: 1. Clinically relevant co-sensitization (others than hazel, alder and elm) expected during the birch-pollen season. 2. Chronic asthma with an FEV1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the number of treatment-related systemic reactions (classified in accordance with the WAO-grading system) in the BM41/VD3 treatment group compared to BM41/Placebo2, VD3/Placebo1 and Placebo1/Placebo2 throughout the pre-seasonal treatment course. This will be determined at every visit according to the reports of the patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Reduction of upper airway response to allergen compared to baseline evaluation (Visit 1) as assessed by a TNPT after the first maintenance shot, before start birch-pollen season at Visit 10 and at end of trial at Visit 12 (after grass/weed pollen seasons). Patients will receive incremental dosages of intranasal birch pollen extract (100, 1,000 and 10,000 AU/ml, HAL Allergy B.V., Leiden, The Netherlands) at baseline to determine the upper airways response and the threshold dose to birch pollen. The upper airways response to intranasal birch pollen extract will be quantified using the symptom score according to Lebel et al.. The mean total symptom score is calculated from the response to the allergen dosage which evoked a positive test. After the preseasonal treatment course before birch-pollen season at Visit 10 and at end of trial at Visit 12 the TNPT will be repeated with the same incremental allergen dosages as used at baseline. The mean total symptom score to the allergen dosage which evokes a positive test at Visit 10 (before birch-pollen season) and at end of trial at Visit 12 will be compared to the baseline values. For a description of the TNPT and the Lebel scores. 2) Improvement in nasal patency compared to baseline evaluation (Visit 1) as assessed by Peak Nasal Inspiratory Flow (PNIF) after TNPT after the first maintenance shot, before birch-pollen season at Visit 10 and at end of trial at Visit 12 (after grass/weed pollen seasons). 3) Furthermore, clinical efficacy will investigated by analyzing the reduction in a combined symptom and medication score (CSMS) as assessed during the birch pollen season. The BM41/VD3 (the combination treatment), the BM41/Placebo 2 (BM41 alone), and the VD3/Placebo1 (VD3 alone) treatment groups will be compared to each other and to Placebo1/Placebo2. This clinical endpoint refers to the recently published EAACI Position Paper on *Recommendations for the standardization of clinical outcomes used i | — |
Countries
Denmark, Germany, Netherlands, Poland
Outcome results
None listed