Controlled allergic bronchial asthma + rhinitis/rhinoconjunctivitis induced by house dust mite
Conditions
Interventions
Product Name: House dust mite allergoid
Product Code: Acaroid 60 strength A
Pharmaceutical Form: Suspension for injection
Other descriptive name: house dust mite allergoid
Concentration unit: PNU/ml p
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Has the patient given informed consent according to local requirements before any trial-related activities? (A trial-related activity is any procedure that would not have been performed during the routine management of the patient.) Is the patient a legally competent male or female outpatient? Is the patient aged 18-40 year? Does the patient suffer from IgE-mediated allergic asthma (controlled, acc. to GINA 2006) + rhinoconjunctivitis induced by house dust mite documented by skin prick test (SPT) wheal for D. pteronyssinus > 3 mm in diameter and histamine (0.1% histamine) wheal >3mm and a negative control reaction (NaCL) wheal 1.5kU/L to D. pteronyssinus and proven clinical relevance of house dust mite allergy by positive conjunctival provocation testing with D. pteronyssinus allergens and main symptoms of asthma and rhinitis in the months September to February or over the entire year on exposure to house-dust mites and requirement of inhaled corticosteroid treatment with Fluticasone equivalent up to a maximum dose of 500µg per day and confirmed asthma diagnosis and asthma classification as “controlled” according to GINA guidelines (version 2006) 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 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Has the patient undergone previous specific immunotherapy with house dust mite allergens in any formulation? Is the patient currently undergoing any sort of immunotherapy? Has the patient ever undergone specific immunotherapy with unknown allergen? Has the patient a sensitisation to storage mites and any other allergen as determined by serum immunoassay that exceeds the sensitisation to Dermatophagoides pteronyssinus or Dermatophagoides farinae more than 10%? Has the patient clinical relevant symptoms to other perennial allergens or sensitisation (SPT > 3mm or immunoassay > 0.7 kUL) against perennial or seasonal allergens which interfere with the assessment period of September to December and can the clinical relevance not be excluded by a provocation test? Does the patient have a positive pregnancy test before the baseline phase? Does the patient use an unacceptable and unreliable contraceptive method during the trial? Is the patient pregnant or wishes to breast feed? Is the patient seeking to become pregnant? And the usual exclusion criteria for immunotherapy regarding health status and medication requirement.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Not applicable;Main Objective: The aim of this clinical trial is to evaluate the optimal dose for efficacy and tolerability of specific immunotherapy with an aluminium hydroxide-adsorbed allergoid preparation of major allergens of D. pteronyssinus in patients with controlled allergic asthma (acc. to GINA 2006) + allergic rhinoconjunctivitis caused by house dust mite.;Primary end point(s): The primary endpoint for evaluating the efficacy of the four different doses of active treatment in comparison to placebo is the absolute change of the swelling area of the late response reaction after intracutaneous testing with a solution of Dermato¬phagoi¬des pteronyssinus from baseline to the measurement after treatment. The concentration injected in the ICT as well as the time-point for the assessment of the late phase reaction is determined in a pre study part that is conducted before the dose finding part.;Timepoint(s) of evaluation of this end point: At baseline before teatment 4th quarter 2012 andt after treatment 4th quarter 2013. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Immunological changes: House-Dust-Mite.-specific IgE, IgG and IgG4 at start of therapy compared to end of treatment The absolute change of the wheal diameter 20 min (early response) after intracutaneous testing with a solution of Dermatophagoides pteronyssinus from baseline to the measurement after one year of treatment. The change of the minimal asthma control dose assessed by Asthma Control Test (ACT) before and after treatment. Change of the score assessed by ACT before and after treatment. The score of ACT will be compared at the same corticoid dose: the first step down dose at baseline without asthma control. Change of morning PEF before and after treatment. Safety of treatments during uptitration and the entire treatment period as assessed by the occurrence of adverse events, the change of laboratory values and vital signs. ;Timepoint(s) of evaluation of this end point: At baseline before teatment Nov. 2012 - Jan. 2013 and after treatment Nov. 2013 - Jan. 2014. | — |
Countries
Poland, Spain
Contacts
Public ContactClinical Trials Information
Allergopharma GmbH & Co. KG
Outcome results
None listed