Efficacy and Safety of Specific Immunotherapy With CLUSTOID Grass Pollen

Study Overview
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Brief Summary
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The objective of this study is to assess the efficacy and safety of cluster immunotherapy with highly polymerized allergen extracts.

Official Title
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Efficacy and Safety of Subcutaneous Cluster Immunotherapy With Cluster-allergoid CLUSTOID Grasses/Rye (Glutaraldehyde-polymerized Allergen Extract of Mixtures of Grass and Rye Allergens) in Patients With Allergic Rhinoconjunctivitis Sensitized to Grass and With or Without Rye Pollen Sensitization

Conditions
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Allergic Rhinitis

Intervention / Treatment
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* Biological: Subcutaneous injections with highly polymerized allergen extract
* Biological: Subcutaneous injection with placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive history of allergic rhinitis/rhinoconjunctivitis due to grass and/or rye pollen Positive screening skin prick test (wheal diameter > 3 mm) Compliance and ability of the patient to complete a Diary Card for self-evaluating of the symptoms and antisymptomatic medication Signed and dated patient´s Informed Consent, Exclusion Criteria: Previous immunotherapy with grass and/or rye pollen extracts within the last 3 years, Simultaneous participation in other clinical trials, Other reasons contra-indicating an inclusion into the trial according to the investigator´s estimation (e.g. poor compliance), Auto-immune disorders, Severe chronic inflammatory diseases, Malignancy, Alcohol abuse, Existing or intended pregnancy, lactation and/or lack of adequate contraceptive protection, Patients being in any relationship or dependency with the sponsor and/or investigator, Treatment with beta-blockers (incl. local application) and/or other contra-indicated drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: highly polymerized allergen extract<br> | Biological: Subcutaneous injections with highly polymerized allergen extract<br>* cluster schedule<br>|
| Placebo Comparator: Placebo<br> | Biological: Subcutaneous injection with placebo<br>* cluster schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom and medication score |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the treatment during the study period |  | 1 year | 
| Documentation of adverse events |  | 1 year | 
| Individual symptom scores of the rhinoconjunctivitis symptom score (RSS) during the pollen season |  | 1 year | 
| Global evaluation and Quality of life questionnaire |  | 1 year |