A multicentre randomised, placebo-controlled, double-blind pivotal clinical trial for the evaluation of safety and efficacy of specific of immunotherapy with an aluminium hydroxide-adsorbed hypoallergenic recombinant derivative of the major birch pollen allergen, rBet v1-FV - Specific immunotherapy with a recombinant birch pollen allerge

• Conditions: ICD classification code: J45.0 and J30.1Patients with moderate to severe seasonal allergic rhinitis with or without controlled bronchial asthma; MedDRA version: 9.1Level: LLTClassification code 10039085Term: Rhinitis allergic; MedDRA version: 9.1Level: LLTClassification code 10001705Term: Allergic asthma

• Registration Number: EUCTR2007-001029-84-SE
• Lead Sponsor: Allergopharma Joachim Ganzer KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-10
• Last Update Posted: 30 September 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 835

Inclusion Criteria

-Male and female outpatients, 18 - 60 years
-Patients suffering from IgE-mediated, moderate to severe 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 at least 5mm (to be demonstrated in a valid skin prick test: negative NaCl control wheal < 3mm, positive Histamine (0.1%) control wheal at least 3mm) and
-positive EAST to birch pollen at least 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

-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, dog, cat:Sensitisation in the Skin Prick Test: wheal diameter of respective interfering allergen = wheal diameter of birch pollen allergen
Clinical relevant 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 (ECCS) or uncontrolled bronchial asthma
-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, heart, kidneys, metabolic diseases)
-Autoimmune diseases, immune-defects including immuno-suppression, immuno-complex-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 Beta-Blockers
-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The aim of this study is to establish superiority of perennial specific immunotherapy with rBet v1-FV over placebo. ;Secondary Objective: 2. to evaluate the safety of the preparation of the folding variant of recombinant major allergen of birch pollen (rBet v1-FV) for perennial treatment<br>3. to assess immunologic parameters during the course of the study in order to obtain evidence of the immunologic effects of the recombinant major allergen of birch pollen<br>;Primary end point(s): Changes in the Symptom medication score (SMS), calculated by the daily sum of allergic symptoms and the daily sum of intake of additional antiallergic medication before vs. after treatments in the double blind study phase. <br>