IgE-mediated allergic disease in adults manifested as rhinitis/ rhinoconjunctivitis and/or allergic asthma bronchiale (GINA I and II) triggered by non eliminable house dust mite allergens.
Conditions
Interventions
Product Name: House dust mite allergoid (Dermatophagoides pteronyssinus)
Product Code: Al0106ac
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injecti
Sponsors
Alllergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ·Patients with IgE-mediated allergic rhinitis/rhinoconjunctivitis with or without bronchial asthma (GINA grade I and II), triggered by house dust mites, documented by means of: ·Positive EAST > 2 to housedust mites, measured by Central Lab and ·Positive prick test reaction to D. pter ·Determination of the nasal airflow recovery after decongestion performed by PNIF For enrolment into the study the patients PNIF after nasal decongestion must be > 100 l/s and an improvement of > 25% after topical nasal decongestion ·positive conjunctival provocation test result against D. pter. allergen extract ·positive house dust mite allergen or microscopic mite determination in bed of the patients living area ·For patients with allergic asthma bronchiale: therapy with max. 500 µg BDP/-equivalent per day and/or ß2- Mimetics when needed should be sufficient ·After the 3 month baseline period only those patients will be included in the treatment phase who demonstate adequate symptomatic in the diary 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 house-dust or storage mites or any unknown allergen ·Patients that have undergone an unsuccessful course of SIT with any allergen ·SIT 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 (October - January): ·Irreversible nasal obstruction caused by nasal structural anomalies. ·Clinically relevant rhinitis/rhinoconjunctival or respiratory symptoms related to other reasons that have not been clearly identified ·FEV1 < 80 % of predicted normal (ECCS) ·bronchial asthma (GINA III + IV) ·Any prophylactic and constant dosage during the diary phase with antiallergic medication ·Previous or ongoing use of anti-IGE antibodys ·Contra-indications for application of adrenaline: -Severe acute or chronic symptomatic coronary heart disease -Severe arterial hypertension ·Treatment with beta-Blockers ·Allergy treatment according to severity of symptoms with other than the following medication during the diary phase: levocabastine nasal spray (0,5 mg/ml each), loratadine/cetirizine tablets (10 mg), oxymetazoline spray 0.05%. Exacerbation treatment with a short course of oral corticosteroids. Unchanged basic treatment with inhaled corticosteroids up to 500 µg BDP/-equivalent and the use of ß2-mimetics as needed is permitted in asthmatics.
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: ·Change of AUC of SMS after 1 year of treatment to baseline ·Immunologic changes: Allergen specific IgE, IgG1 and IgG4 ·Change of nasal ECP level after 2 years of treatment (only in selected trial centres) to baseline ·Tolerability and safety will be assessed during the initial treatment phase and after each injection by evaluating adverse events and other parameters. ;Primary end point(s): The primary endpoint of this study is the change of the area under the curve (AUC) of the Symptom-Medication-Score (SMS) after 2 years of double-blind treatment to baseline. For this purpose patients will carefully complete a diary over a time period of anticipated 3 months in the winter time of 2006/2007 and six weeks during winter time 2007/2008 and 2008/2009. A Symptom-Medication-Score (SMS) will be calculated by the daily sum of allergic symptoms and the daily sum of additional antiallergic medication intake. The accurate keeping of the diary will be checked by the investigator. A predefined diary phase will be used for assessment of clinical efficacy. Further details will be defined in the statistical analysis plan (SAP). | — |
Countries
Germany
Outcome results
None listed