Dose-Response-Study With a Recombinant Cocktail of Phleum (rPhleum) Allergens

Study Overview
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Brief Summary
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Dose-response trial with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense)

Official Title
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A Double-blind Placebo-controlled Dose-response Study for Evaluation of Safety and Efficacy of Immunotherapy With a Cocktail of Recombinant Major Allergens of Timothy Grass Pollen (Phleum Pratense) Adsorbed to Aluminium Hydroxide in Patients With IgE-mediated Allergic Rhinitis/Rhinoconjunctivitis With or Without Bronchial Asthma

Conditions
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Type I-Allergy

Intervention / Treatment
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* Drug: placebo
* Biological: rPhleum
* Biological: rPhleum
* Biological: rPhleum
* Biological: rPhleum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: main symptoms of allergic rhinitis/rhinoconjunctivitis with or without controlled asthma against grass pollen allergens positive SPT positive EAST positive specific provocation test Exclusion Criteria: serious chronic diseases other perennial allergies

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4. | Drug: placebo<br>* Placebo: Al(OH)3-Placebos with histamine-dihydrochloride analogue Allergen-Adsorbate rPhleum strengthes 1 to 4.<br>* Other names: Comparator;|
| Experimental: 20 μg rPhleum Immunotherapy<br>Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg) | Biological: rPhleum<br>* Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 1 (20 μg)<br>* Other names: Specific Immunotherapy;|
| Experimental: 40 μg rPhleum Immunotherapy<br>Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg) | Biological: rPhleum<br>* Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 2 (40 μg)<br>* Other names: Specific Immunotherapy;|
| Experimental: 80 μg rPhleum Immunotherapy<br>Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg) | Biological: rPhleum<br>* Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 3 (80 μg)<br>* Other names: Specific Immunotherapy;|
| Experimental: 120 μg rPhleum Immunotherapy<br>Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg) | Biological: rPhleum<br>* Cocktail of recombinant major allergens of Phleum pratense (timothy grass) with strength 4 (120 μg)<br>* Other names: Specific Immunotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic reaction (according to Tryba) | Number of patients with at least one systemic reaction (according to Tryba Grade 1-4) with possible, probable or definite relationship to the study medication determined at the end of the uptitration phase. | uptitration phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late Phase Reactions | Changes of the Late Phase Reactions in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season. | before and at the end of the double-blind phase |