ICD classification code: J45.0 and J 30.1 Rhiniconjunctivitis +/- asthma bronchiale MedDRA version: 15.0 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 15.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: Cocktail of recombinant major allergens of Phleum pratense
Product Code: rPhleum
Pharmaceutical Form: Suspension for injection
Current Sponsor code: rPhleum
Concentration unit: µg/ml mic
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has the subject given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the subject and any other trial-related activity performed with trial specific diagnostics or with trial medication) 2. Is the subject a legally competent male or female outpatient? 3. Is the subject aged 12 - 65 year? 4. Does the subject suffer from IgE-mediated seasonal allergic rhinoconjunctivitis with or without asthma (controlled, acc. to GINA 2006) caused by grass pollen documented by o skin prick test wheal for grass pollen = 5mm in diameter and o histamine (1,0% histaminedihydrochloride) wheal = 3mm and o NaCl control reaction =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -unable to understand and comply with the requirements of the trial, as judged by the investigator -currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial -involved in the planning and conduct of the trial -an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites -any relationship of dependence with the sponsor and/or with the investigator -previously enrolled or randomised to treatment in the present trial -mentally disabled -institutionalised due to an official or judicial order For females with childbearing potential : -a positive pregnancy test before the baseline phase -use an unacceptable and unreliable contraceptive method during the trial, as judged by the investigator -pregnant or within the lactation period -seeking to become pregnant Immunotherapy criteria: -undergone previous specific immunotherapy with grass pollen allergens in any formulation -currently undergoing any sort of immunotherapy -ever undergone specific immunotherapy with unknown allergen or an unsuccessful immunotherapy -For allergens which interfere with the grass pollen season for all participating countries: Plantain, nettle, mugwort, alternaria alternata, Dermatophagoides farinae, Dermatophagoides pteronyssinus Additionally the following allergens will be tested in the following countries: Spain: olive tree, cat epithelia, dog epithelia UK: aspergillus, cat epithelia, dog epithelia PL: cat epithelia, dog epithelia D: cat epithelia, dog epithelia •skin prick test a wheal diameter of respective interfering allergen = wheal diameter of grass pollen allergen or •Sensitisation to respective interfering allergen as determined by serum EAST = sensitisation to grass pollen? Additionally for France: a sensitisation to cat or dog allergens as determined by serum EAST = 0,35kU/l -suffer from any clinically relevant perennial allergies (e.g. cat, mite) and clinical relevance can not be excluded Disease and health status: -show a total IgE of > 2000kU/l -suffer from clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons -PEF or FEV1 < 80% of predicted normal (ECSC) -uncontrolled or partly controlled asthma according to GINA guidelines (version 2006) -suffer from perennial and continuously treated asthma -suffer from rhinoconjunctival atopy symptoms for 20 years or longer -suffer from severe acute or chronic diseases (e.g. Diabetes mellitus type I, malignant neoplasia, chronic renal failure), severe inflammatory diseases -suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies -suffer from severe psychiatric and psychological disorders including impairment of cooperation -suffer from recurrent seizures? -suffer from irreversible secondary alterations of the reactive organ -any physiological and laboratory variables within/outside normal limits and as reported to be greater than Grade 1 changes according to the FDA Guidance for Industry an/or normal for population -treated with beta-blockers (locally and systemically) -any contraindication for use of adrenalin -completed or has an ongoing treatment with anti-IgE-antibody -completed or has an ongoing long-term treatment with tranquilizer or other psychoactive drugs -treated for allergy or asthma according to severity of symptoms with other than the following medication during t
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this clinical trial is to prove the hypothesis that the recombinant allergen preparation rPhleum is suitable for an efficacious SCIT in grass pollen allergic patients and that the trial preparation is sufficient to suppress allergic symptoms caused by natural grass pollen exposure. The trial medication will be tested versus placebo in a total of 228 subjects. ;Secondary Objective: 1)Changes of AUC of the medication-adjusted Rhinoconjunctivitis Symptom Score (ma RC-SS) after 1 and 3 years. 2)Changes of AUC of the Rhinoconjunctivitis Symptom-Medication-Score (RC-SMS) after 1, 2 and 3 years. 3)Changes of AUC of the rhinoconjunctivitis symptom score after 1, 2 and 3 years. 4)Changes of AUC of the rhinoconjunctivitis medication score after 1, 2 and 3 years. 5)Changes of AUC of the total Symptom-Medication-Score of rhinoconjunctivitis and asthma (SMS) after 1, 2 and 3 years. 6)Changes of AUC of the total symptom score after 1, 2 and 3 years. 7)Changes of total medication score after 1, 2 and 3 years. 8)Immunologic changes: specific IgGand IgG4. 9)Improvement in specific conjunctival provocation. 10)Well days based on RC-SMS (no medication intake and maximum 2 score points). 11)Response status in terms of 40% improvement for the primary variable for an individual trial subject as compared to baseline. 12)Change of EQ-5D (before vs. after treatment). ;Primary end point(s): The primary endpoint of this trial is the change of the area under the curve (AUC) of the medication-adjusted Rhinoconjunctivitis Symptom Score (ma-RC-SS) from the baseline season to the season after 2 years of treatment. ;Timepoint(s) of evaluation of this end point: see section E.5.1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Changes of AUC of the medication-adjusted Rhinoconjunctivitis Symptom Score (ma RC-SS) after 1 and 3 years. 2) Changes of AUC of the Rhinoconjunctivitis Symptom-Medication-Score (RC-SMS) after 1, 2 and 3 years. 3) Changes of AUC of the rhinoconjunctivitis symptom score after 1, 2 and 3 years. 4) Changes of AUC of the rhinoconjunctivitis medication score after 1, 2 and 3 years. 5) Changes of AUC of the total Symptom-Medication-Score of rhinoconjunctivitis and asthma (SMS) after 1, 2 and 3 years. 6) Changes of AUC of the total symptom score after 1, 2 and 3 years. 7) Changes of total medication score after 1, 2 and 3 years. 8) Immunologic changes: specific IgGand IgG4. 9) Improvement in specific conjunctival provocation. 10) Well days based on RC-SMS (no medication intake and maximum 2 score points). 11) Response status in terms of 40% improvement for the primary variable for an individual trial subject as compared to baseline. 12) Change of EQ-5D (before vs. after treatment).;Timepoint(s) of evaluation of this end point: see section E.5.2 | — |
Countries
France, Germany, Poland, Spain, United Kingdom
Contacts
Public ContactKaren Gessner
Allergopharma Joachim Ganzer KG
Outcome results
None listed