A multicentre, multinational randomised placebo-controlled double-blind pivotal clinical trial for evaluation of safety and efficacy of specific im-munotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) adsorbed onto aluminium-hydroxide in patients with IgE-mediated allergic rhinoconjunctivitis with/ without con-trolled asthma (AMETHYST) - AMETHYST

Active, not recruiting

• Conditions: IgE-mediated allergic rhinoconjunctivitis with/without controlled bronchial asthma triggered by grass pollen allergens; MedDRA version: 9.1Level: LLTClassification code 10048908Term: Seasonal allergy

• Registration Number: EUCTR2007-003208-37-IT
• Lead Sponsor: ALLERGOPHARMA JOACHIM GANZER KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06-03
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 228

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 grass pollen  In the course of the year: Major allergy symptoms during grass pollen season  Symptoms of allergic rhinoconjunctivitis against grass pollen allergens requiring medication during the last grass pollen season  Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test (CPT) result using natural grass pollen cocktail  Positive skin prick test reaction to natural grass pollen allergens demonstrated by grass pollen allergen weal diameter  5mm (to be demonstrated in a valid skin prick test: Negative NaCl control weal  3 mm, positive Histamine (0.1%) control weal  3 mm)  Positive EAST to grass pollen  1.5 kU/L to be determined in central laboratory  For female patients: effective contraception and negative pregnancy test result. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectibles, combined or oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. No pharmacological interactions are known for hormonal contraceptives and specific immunotherapeutic preparations.
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 hyposensitisation against grass pollen or unknown other allergens in any pharmaceutical form  Patients who have undergone an unsuccessful course of specific im-munotherapy with any allergen  For allergens which interfere with the grass pollen season during May to August (Plantain, Nettle, Olive tree, Parietaria officinalis, Alternaria alternata, Cat epithelia, Dermatophagoides farinae, Dermatophagoides pteronyssinus):sensitisation in the Skin Prick Test: o Weal diameter of respective interfering allergen ≥ weal diameter of grass pollen allergen o Sensitisation as determined by serum EAST >1.5 kU/L  Clinical relevant sensitisation has to be excluded in a provocation test  Clinically relevant rhinoconjunctival or respiratory symptoms related to other reasons than allergy  PEF or FEV1< 80% of predicted normal (ECCS) or uncontrolled/partly controlled 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, immune-complex-induced immunopathies  Severe psychiatric and psychological disorders including impairment of cooperation (e.g. alcohol or drug abuse)  Completed or ongoing long-term treatment with tranquilizer psycho ac-tive drug  Allergy treatment according to severity of symptoms with other topical steroids than the following medication during the baseline grass pollen season: Levocabastine nasal spray/ eye drops (0.5 mg/ml each), Loratadine/Cetrizine tablets (10 mg), Salbutamol 100 micro-gram/puff) Treatment of exacerbation of allergic rhinoconjunctivitis and bronchial asthma with a short course of oral corticosteroids is permitted. Treatment with or other medication must be stopped 2 weeks prior to start of this study. Basic asthma treatment with other medication than short acting bronchodilatators  Any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the baseline and any grass pollen seasons during 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  Low compliance or inability to understand instructions/study docu-ments  Completed or ongoing treatment with Anti-IgE antibody  Patients being in any relationship of dependence with the sponsor and/or investigator  Contraindication for adrenaline, (e.g. acute or chronic symptomatic coronary heart disease, severe arterial hypertension)  Treatment with beta-Blockers, locally and systemically

Study & Design

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