IgE-mediated allergic disease in adults and children manifested as bronchial asthma (GINA II and III) +/-allergic rhinitis/rhinoconjunctivitis, triggered by non-eliminable house dust mite allergens.
Conditions
Interventions
Product Name: House dust mite allergoid (Dermatophagoides pteronyssinus)
Product Code: Al 0104 av
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injec
Sponsors
ALLERGOPHARMA JOACHIM GANZER KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with IgE-mediated clinically relevant sensitation against house-dust mite allergens manifested as bronchial asthma (GINA grade II and III) +/- allergic rhinitis/rhinoconjunctivitis verified by: Full reversibility of FEV1 Asthma symptoms according to GINA II or III on exposure to house-dust mites Positive Prick Test reaction to D.pter. Positive RAST/CAP to D. pter. at least Class 2 Positive conjunctival provocation test result against D.pter. Requirement of asthma treatment with inhaled short-acting ß2-agonist and Requirement of inhaled corticosteroid treatment Are the trial subjects under 18? yes 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: Lung function: FEV1 < 80 % of predicted normal (ESCS) under optimum treatment Previous course of hyposensitation against house-dust or storage mites or any unknown allergen Unsuccessful course of specific immunotherapy with any allergen Specific immunotherapy with any other allergens during the course of the study Symptoms related to or skin test positivity to other perennial or seasonal allergens which interfere with the annual diary phases (Sept. 15th-February 15th): a) if clinically relevance cannot be excluded by provocation testing (alder, hazel, moulds) b) if allergen contact on more than 2 occasion monthly cannot be excluded (cat, dog)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate efficacy and tolerability of specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of major allergens of D. pteronyssinus;Secondary Objective: Nonspecific bronchial hyperreactivity: change of PD20 FEV1 Immunologic changes: specific IgE, IgG1, IgG4 Changes in symptoms before versus after treatment Changes in use of bronchodilator rescue medication (Salbutamol) before versus after treatment Change in pre-bronchodilator morning peakflow before versus after treatment ;Primary end point(s): Intraindividual changes of the minimum dose of inhaled corticosteroid to achieve asthma control (according to GINA criteria) compared with the period before treatment | — |
Countries
Germany
Outcome results
None listed