IgE-mediated allergic diseases including symptoms of allergic rhinoconjunctivitis, controlled allergic bronchial asthma, triggered by grass/rye pollen allergens
Conditions
Interventions
Trade Name: Allergovit
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: 6 Gramíneas (80%) + Centeio (20%)
CAS Number: NA
Concentration unit: U/ml unit(s)/millilitre
Concentration typ
Sponsors
Allergopharma Joachim Ganzer KG an afilliate of Merck KGaA, Darmstadt
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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/Secale pollen; - In the course of the year: major allergy symptoms during grass/Secale pollen season; - Symptoms of allergic rhinoconjunctivitis against grass/Secale pollen allergens requiring medication during the last grass pollen season; - Proven clinical relevance of grass pollen allergy by positive conjunctival provocation test result using a natural grass pollen extract; - Positive Prick Test reaction to grass pollen allergens demonstrated by allergen wheal diameter > 3mm (to be demonstrated in a valid skin prick test: nega¬tive NaCl control wheal 3mm); - Positive EAST to grass pollen ? 1.5 kU/L to be determined in central laboratory; 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 hyposensitisation against grass pollen or any unknown allergen - Patients that have undergone an unsuccessful course of specific immunotherapy with any allergen - Symptoms related to or strong skin test positivity (weal diameter ? than diameter of the grass pollen weal) to birch, parietaria, mugwort, oak, olive tree, plane tree - PEF or FEV1 < 80 % of predicted normal (ECCS) or uncontrolled bronchial asthma Contra-indications for application of adrenaline: - Severe acute or chronic diseases, severe inflammatory diseases ary heart disease - Severe arterial hypertension - Treatment with ?-Blockers, locally and systemically - Completed or ongoing treatment with anti-IgE-antibody -
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint of the study is the number of patients with an improvement of the theshold concentration eliciting a positive Conjunctival Provocation Test (CPT) with grass plus rye allergens after 2 pre-seasonal short treatment courses with the allergoid preparation compared to placebo under double-blind conditions.;Main Objective: The aim of this CT is to prove the hypothesis that the allergoid preparation of an extract of a grasses plus rye pollen mixture is suitable for an efficacious treatment of grass pollen allergic patients with SIT and that the trial preparation is sufficient to suppress allergic symptoms caused by natural grass pollen exposure. A quantitative Conjunctival Provocation Test (CPT) will be performed before treatment to determine the individual threshold concentration defined by the lowest concentration of a grass plus rye pollen extract eliciting a positive allergic reaction (irritation/pruritus and redness/hyperemia) in the conjunctiva of a patient. Primary endpoint is o determine the number of patients with an improvement of the threshold concentration in October 2009 after 2 years of treatment a CPT with the individual threshold concentration only will be performed. ;Secondary Objective: • Changes in patients´ assessment of rhinoconjunctivitis at the end of the grass pollen season accor¬¬ding to a Visual Rating Scale after 1, 2, and 3 years • Number of patients with an improvement of the conjunctival provocation threshold concentration after 1 and 3 years • Immunologic changes: Allergen specific IgG4. • Tolerability and safety will be assessed during the initial treatment phase and after each injection by evaluating the documentation of adverse events and other para¬meters. | — |
Countries
Portugal
Outcome results
None listed