Allergic Rhinitis, Allergic Rhinoconjunctivitis
Conditions
Keywords
immunotherapy, birch pollen, seasonal allergy, up-dosing
Brief summary
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Birch will be evaluated in a rush regimen (maximum dose reached in 3 injections during 3 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 6 weeks). The primary endpoint of the sudy is the comparison of the proportions of the patients who have successfully reached the maintenance dose between the two treatment regimes. A similar previous study with PURETHAL Grasses has shown that the rush up-dosing scheme is as safe as the conventional up-dosing regime. Therefore it is expected that up-dosing with PURETHAL Birch according to the rush regimen is as safe as using the conventional regimen.
Interventions
BIOLOGICALPURETHAL Birch, 20.000 AUM/ml
comparison of different up-dosing regimes
Sponsors
Ergomed
HAL Allergy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed informed consent. * Age ≥12 years. * Allergic rhinitis/rhinoconjunctivitis related to birch pollen with or without concomitant mild to moderate persistent asthma * FEV1\>70% for patients with a history of mild to moderate asthma, FEV1\>70% or PEF\>80% for patients without a history of asthma * A positive SPT (mean wheal diameter ≥ 3mm compared to negative control and negative control should be negative) for birch pollen. * Positive serum specific anti-birch IgE-test (\>0.7 U/ml) within 1 year before randomization and/or a positive provocation test for birch pollen within 1 year before randomization.
Exclusion criteria
* Immunotherapy (SCIT or SLIT) with birch pollen allergens within the past 5 years * Any specific immunotherapy (SCIT or SLIT) during the study period * Severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs * Active malignancies or any malignant disease within the past 5 years * Severe uncontrolled diseases that could increase the risk for patients participating in the study * Acute/active inflammation or infection of the target organs at the start of the study * Secondary changes of the target organ * Diseases with a contraindication for the use of adrenaline * Use of systemic steroids within 4 weeks before start of the study and during the study * Treatment with systemic and local β-blockers * Vaccination within one week before start of therapy or during the initiation phase * Anti-IgE therapy within the 6 months prior to inclusion and during the study * Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study * Pregnancy, lactation or inadequate contraceptive measures for women of child-bearing age * Alcohol, drug or medication abuse within the past year * Any clinically significant abnormal laboratory parameter at screening * Lack or expected lack of cooperation or compliance * Severe psychiatric, psychological, or neurological disorders * Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients successfully reaching the maintenance dose | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Early and late local and systemic reactions | 30 minutes after IMP injection and 24 hours after injection |
| Immunological parameters (IgE, IgG) | 10 weeks rush regime, 13 weeks conventional regime |
Countries
Poland
Outcome results
None listed