Allergic (IgE-mediated) rhinitis / rhinoconjunctivitis triggered by house dust mites. MedDRA version: 9.1 Level: LLT Classification code 10001725 Term: Allergic rhinitis due to other allergen MedDRA version: 9.1 Level: LLT Classification code 10053713 Term: Allergenic desensitisation procedure MedDRA version: 9.1 Level: LLT Classification code 10053741 Term: Allergenic desensitization procedure MedDRA version: 9.1 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis
Conditions
Interventions
Product Name: PURETHAL Mites
Product Code: PM
Pharmaceutical Form: Injection*
Sponsors
HAL Allergy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients with rhinitis or rhinoconjunctivitis, with or without mild asthma (FEV1 > 70%) for at least 2 years (their allergic symptoms must be related to HDM) • Positive CPT test to HDM Der p and Der f, dose =10,000 AUeq/ml • Positive SPT to HDM Der p and Der f (mean wheal diameter = 3mm) • Specific serum IgE-test (ssIgE > 0.7 U/ml) for HDM • Age = 18 years • Patients must give a written informed consent prior to inclusion 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Concomitant sensitization i.e. positive SPT (mean wheal diameter = 3 mm) to other allergens than HDM, grass pollen, tree pollen or pets • Patients sensitized to grass pollen should not be starting treatment or evaluated during the period of grass pollen exposure • Patients sensitized to tree pollen should not be starting treatment or evaluated during the period of tree pollen exposure • Patients sensitized to both grass - and tree pollen • Patients sensitized to pets should not be included if they live together with these pets or have clinical symptoms • Immunotherapy (including sublingual) with HDM within the last 5 years • Immunotherapy (including sublingual) during the study period • Chronic asthma or emphysema, particularly with a FEV1 = 70% of predicted value or use of inhalation corticosteroids • Serious immuno-pathologic diseases or malignancies (including auto-immune diseases, tuberculosis) • Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension • Diseases with a contra-indication for the use of adrenaline • Patients who are using other aluminium preparations, e.g. antacids • Severe kidney disease • Use of systemic steroids • Treatment with systemic and local ß-blockers or immunosuppressive drugs • Active infection of the target organs (nose or eyes) • Severe atopic dermatitis in case systemic immunosuppressive medication is used • Participation in a clinical study with a new investigational drug within the last 3 months • Pregnancy, lactation or inadequate contraceptive measures (adequate contraceptive measures will be the use of a contraceptive device or -pill) • Alcohol- or drug abuse • Lack of co-operation or severe psychological disorders • Institutionalisation by official or judical order
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to establish the maximum tolerated dose of PURETHAL Mites that is achieved by 90% of the patients with less than 20% of the injections giving rise to a swelling of > 5 cm and the optimal regimen to reach this maximum dose will be determined.;Secondary Objective: The secondary objectives of this trial are to monitor the safety of the injections and to measure short-term efficacy of the treatment.;Primary end point(s): Early local reactions (ELR) occurring 15 minutes after injection. Less than 20% of the injections should give rise to swelling at the injection site of >5cm in diameter occurring 15 minutes after injection. | — |
Countries
Germany
Outcome results
None listed