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
Sponsors
ALLERGOPHARMA JOACHIM GANZER KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female outpatients, 18 - 60 years - Patients suffering from IgE-mediated, seasonal allergic rhinitis with or without controlled bronchial asthma (PEF and/or FEV1 at least 80% predicted normal) attributable to birch pollen and - In the course of the year: major allergy symptoms during birch pollen season and - symptoms of allergic rhinoconjunctivitis against birch pollen allergens requiring medication during the last birch pollen season and - proven clinical relevance of birch pollen allergy by positive conjunctival provocation test result using natural birch pollen extract and - positive skin prick test reaction to natural birch pollen allergens demonstrated by birch pollen allergen wheal diameter > 5mm (to be demonstrated in a valid skin prick test: negative NaCl control wheal 3mm) and - positive EAST to birch pollen = 1.5 kU/L to be determined in central laboratory - 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 tree pollens or unknown other allergens in any pharmaceutical form - Patients who have undergone an unsuccessful course of specific immunotherapy with any allergen - For allergens which interfere with the birch pollen season: alder, hazel, beech, Dermatophagoides farinae, Dermatophagoides pteronyssinus, dog, cat: • Sensitisation in the Skin Prick Test: wheal diameter of respective interfering allergen = wheal diameter of birch pollen allergen • Sensitisation as determined by serum EAST - Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons than allergy - PEF or FEV1 < 80% of predicted normal (ECSC) or uncontrolled bronchial asthma according to the GINA Guidelines (2006) - Febrile infections or inflammation of the respiratory tract at the time of inclusion - Irreversible secondary alterations of the reactive organ (emphysema, bronchiectasis etc.) - Severe acute or chronic diseases, severe inflammatory diseases - Other severe generalised diseases (liver, kidneys, metabolic diseases) - Autoimmune diseases, immune-defects including immuno-suppression, immunocomplex- induced immunopathies - Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse) - Allergy treatment according to severity of symptoms with other than the following medication during the baseline birch pollen season: • Levocabastine nasal spray/eye drops (0.5mg/mL each), Loratadine/Cetirizine tablets (10mg), Salbutamol (100µg/puff). • Treatment of exacerbation of allergic rhinoconjunctivitis and bronchial asthma with a short course of oral corticosteroids is permitted. Treatment with other medication must be stopped 2 weeks prior to start of this study. • Basic asthma treatment with other medication than short acting bronchodilators - Any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the baseline and any birch pollen seasons during the study - Treatment with ß-blockers (locally and systemically) - 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 - Low compliance or inability to understand instructions/study documents - Completed or ongoing treatment with anti-IgE-antibody - Possible dependence of patients on sponsor or investigator - Completed or ongoing long-term treatment with tranquilizer or psychoactive drugs - Contra-indication for adrenalin (for example, acute or chronic symptomatic coronary heart disease, severe hypertension)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to evaluate immunohistological changes and tolerability of specific immunotherapy with rBet v1-FV.;Secondary Objective: To evaluate the safety of the preparation of the folding variant of recombinant major allergen of birch pollen (rBet v1-FV) for perennial treatment.;Primary end point(s): The primary endpoint is the descriptive evaluation of the changes in populations of inflammatory cells and subpopulations of immunologically active cells. The subpopulations which will be evaluated are cells considered central in allergic inflammation. All these cells will be evaluated in nasal biopsies obtained before the start of the treatment (outside the birch pollen season) and during treatment and at the birch pollen season | — |
Countries
Sweden
Outcome results
None listed