PURETHAL Grasses Rush Study

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Randomized, Open, Multi-centre Study to Assess Safety of PURETHAL Grasses Given With a Rush Induction Schedule to Patients With Allergic Rhinoconjunctivitis

Conditions
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Allergic Rhinitis, Allergic Rhinoconjunctivitis

Intervention / Treatment
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* Drug: PURETHAL Grasses, 20.000 AUM/ml


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional regimen of PURETHAL Grasses<br>Initial treatment: 6 incremental weekly subcutaneous doses of 0.05, 0.1, 0.2, 0.3, 0.4 and 0.5 ml (week 1, 2, 3, 4, 5, 6). Maintenance treatment: 0.5 ml in intervals according to registered scheme (week 8, 10, 12, 16). | Drug: PURETHAL Grasses, 20.000 AUM/ml<br>* subcutaneous injections of increasing doses according to the described regimen<br>|
| Experimental: rush regimen of PURETHAL Grasses<br>Initial treatment: 3 incremental weekly subcutaneous doses of 0.1, 0.3, and 0.5 ml (week 1, 2, 3) Maintenance treatment: 3 monthly doses of 0.5 ml (week 7, 11, 15). | Drug: PURETHAL Grasses, 20.000 AUM/ml<br>* subcutaneous injections of increasing doses according to the described regimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systemic reactions > grade I or large local reactions related to injection |  | 24 hrs after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific serum IgE and IgG concentrations |  | 16 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunotherapy, grass pollen, seasonal allergy, dose tolerability