Allergic Rhinitis, Allergic Rhinoconjunctivitis
Conditions
Keywords
immunotherapy, grass pollen, seasonal allergy, dose tolerability
Brief summary
This study investigates the safety of two up-dosing regimen. The safety of PURETHAL Grasses will be evaluated in a rush regimen (maximum dose reached in 3 injections during 2 weeks) compared to the conventional regimen (maximum dose reached in 6 injections during 5 weeks). The primary parameter will be the proportion of patients who experience systemic reactions \> grade I within 24 hours after injection or who need more than 2 additional injections during the up-dosing phase until the maintenance dose has been reached. It is expected that up-dosing PURETHAL Grasses according to the rush regimen is as safe as using the conventional regimen.
Interventions
DRUGPURETHAL Grasses, 20.000 AUM/ml
subcutaneous injections of increasing doses according to the described regimen
Sponsors
HAL Allergy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 \> 70%) for at least 2 years related to grass pollen, eligible for SCIT. * Confirmation of IgE-mediated allergy by means of: * Positive SPT to grass pollen (mean wheal diameter ≥ 3 mm and negative control truly negative (no reaction), or * Specific serum IgE-test (ssIgE \>0.7 U/ml) for grass pollen, or * Positive provocation test for grass pollen. * Age ≥ 18 years. * Patients have given a written informed consent
Exclusion criteria
* Chronic asthma or emphysema, particularly with a FEV1 ≤ 70% of predicted value. * Serious immuno-pathological diseases or malignancies (including auto-immune diseases, tuberculosis, HIV). * Active inflammation/infection of the target organs (nose, eyes, lungs). * Severe atopic dermatitis in need for systemic immunosuppressive medication. * Symptomatic coronary heart diseases (e.g heart failure, recent myocardial infarction, unstable angina, serious arrhythmias) or severe (even under treatment) arterial hypertension. * Severe kidney disease. * Diseases with a contra-indication for the use of adrenaline. * Treatment with systemic or local beta-blockers or immunosuppressive drugs. * History of life threatening anaphylactic events, including anaphylactic food allergy, insect venom anaphylaxis, exercise or drug induced anaphylaxis. * Any specific immunotherapy (including sublingual) during the study period or during the previous 3 years for a period longer than three months. * Participation in a clinical study with a new investigational drug within the last three months. * Pregnancy, lactation or inadequate contraceptive measures (adequate measures: oral contraceptives, IUD, condom use if used together with a spermicide and having no sexual relationship with a man). * Alcohol or drug abuse. * Lack of co-operation or severe psychological disorders. * Completed or ongoing long-term treatment with tranquilizer or psycho active drugs. * Low compliance or inability to understand instructions/study documents. * Completed or ongoing treatment with anti-IgE-antibody. * Patients being in relationship or dependence with the sponsor or investigator. * Allergy to any of the excipients. * Severe illness or any other condition, which makes the patient, in the opinion of the investigator, unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| systemic reactions > grade I or large local reactions related to injection | 24 hrs after injection |
Secondary
| Measure | Time frame |
|---|---|
| specific serum IgE and IgG concentrations | 16 weeks |
Countries
Germany
Outcome results
None listed