ICD classification code: J45.0 and J30.1 MedDRA version: 9.1 Level: LLT Classification code 10039085 Term: Rhinitis allergic MedDRA version: 9.1 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Product Name: Cocktail of recombinant major allergens of Phleum pratense
Product Code: rPhleum
Pharmaceutical Form: Suspension for injection
Other descriptive name: rPhleum
Concentration unit: µg/ml m
Sponsors
ALLERGOPHARMA JOACHIM GANZER KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female outpatients, 18-50 years - Patients with IgE-mediated, moderate to severe seasonal allergic rhinitis with controlled asthma (FEV1 at least 80% predicted normal according to ECCS (GINA 2006)), attributable to grass pollen allergens - Main symptoms of allergic rhinitis/rhinoconjunctivitis against grass pollen allergens and - Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test result using natural grass pollen extract and - Positive prick test reaction to natural grass pollen allergen demonstrated by allergen weal at least as large as histamine control reaction (histaminedihydrochloride 1,7mg/ml histamine, 0,1%) and > 5 mm diameter and a negative control test (saline solution). A positive histamine control reaction is demonstrated by weal diameter >=3mm, a negative control test is demonstrated by weal diameter = 2 measured by Central Lab - For female patients: effective contraception and negative pregnancy test result Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Previous course of hyposensitation against grass pollen or other allergens that are not known - Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen - Symptoms during the months Nov-April and skin test positivity (weal diameter = histamine 0,1% or >= 5 mm) to birch alder, hazel, Dermatophagoides pteronyssinus, Dermatophagoides farinae, dog, cat, Aspergillus, Penicillium. Alternaria and Cladosporium if clinical relevance of this sensitisation cannot be excluded by provocation test. - Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified - FEV1 < 80 % of predicted normal (ECCS) or partly controlled/uncontrolled bronchial asthma according to GINA 2006 - Patients that are not adequately treated with a short acting ß2-Mimetic and 500 µg BDP or 400µg budesonide (equiv.). - Vasomotor, drug-induced or other kinds of non allergic rhinoconjunctivitis - Febrile infections or inflammation of the respiratory tract at time of inclusion - Irreversible secondary alterations of the reactive organ - Severe acute or chronic diseases, severe inflammatory diseases - Other severe generalised diseases (liver, kidneys, metabolic diseases, heart, vascular diseases) -contra-indication for adrenaline (for example acut or chronic symptomatic coronary heart disease, severe hypertension) - Autoimmune diseases, immune-defects including immuno-suppression, immune-complex-induced immunopathies - Multiple sclerosis, active tuberculosis -complete or ongoing treatment with transquillizer or psychoactive drugs - Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) - Treatment that could interfere with safety and/or efficacy of the study drug (e.g. treatment with beta-Blockers (locally and systemic), systemic glucocorticoids, leucotrien-antagonists, anti-IgE etc.) during the course of the study - Pregnancy and lactation period - Female patients seeking to become pregnant - Concurrent participation in any other clinical trial or participation in any other clinical trial during the previous 30 days - Patients being in any relationship of dependence with the Sponsor and/or with the Investigator. - Low compliance or inability to understand instructions/study documents
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This trial is 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) absorbed onto aluminium hydroxide. The aims of this clinical trial are: 1. to prove the safety and efficacy of 4 concentrations of SIT with a cocktail of recombinant major allergens of timothy grass pollen 2. to evaluate the efficacy of the different dosages in conjunctival provocation test and in intracutaneous test with natural allergen before and after pre-seasonal treatment 3. to assess immunologic parameters during the course of the study in order to obtain evidence of the immunologic effects of the cocktail of recombinant major allergens of timothy grass pollen and to evaluate possible correlations with the clinical outcome ;Secondary Objective: 1. Changes in specific conjunctival reactivity in provocation test with natural allergen before and at the end of the double-blind placebo controlled phase before grass pollen season 2. Changes of the Late Phase Reaction in specific intracutaneous test with natural allergen before and at the end of the double-blind placebo-controlled phase before grass pollen season 3. Immunologic changes: Allergen specific IgE, IgG1 and IgG4.;Primary end point(s): The primary endpoint of this study is the number of patients with at least one systemic reaction (According to Tryba 1-4) with possible, probable or definite relationship to the study medication determined at the end of the double-blind placebo controlled phase | — |
Countries
Germany
Outcome results
None listed