Immunoglobulin E (IgE)-mediated allergic disease in adults and adolescents manifested by allergic rhinitis/rhinoconjunctivitis with or without controlled allergic asthma bronchiale (Global Initiative for Asthma [GINA]) triggered by non eliminable house dust mite allergens. MedDRA version: 12.0 Level: LLT Classification code 10039085 Term: Rhinitis allergic MedDRA version: 12.0 Level: LLT Classification code 10001705 Term: Allergic asthma
Conditions
Interventions
Product Name: House dust mite allergoid (Dermatophagoides pteronyssinus)
Pharmaceutical Form: Suspension for injection
Other descriptive name: house dust mite allergoid
Concentration unit: U/ml unit(s
Sponsors
Allergopharma Joachim Ganzer KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Has the subject 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 subject.) 2. Is the subject a legally competent male or female outpatient? 3. Is the subject aged 12 - 60 years? 4. Does the subject suffer from IgE-mediated seasonal allergic rhinitis/rhinoconjunctivitis with or without asthma (controlled, acc. to Global Initiative for Asthma [GINA] 2006) documented by: o SPT wheal for D. pter. =5 mm in diameter and o Histamine (1% histamine) wheal =3 mm and o NaCl control reaction =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Is the subject unable to understand and comply with the requirements of the trial? - Does the subject show a total IgE of >2000 kU/l? - Is the subject currently participating in any other trial or has the subject participated in any other trial within 30 days before inclusion in this trial? - Is/was the subject involved in the planning and conduct of the trial, an employee of Allergopharma Joachim Ganzer KG or of one of the trial sites or in any relationship of dependence with the sponsor and/or with the investigator? - Has the subject been previously enrolled or randomised to treatment in the present trial? - Is the subject mentally disabled or institutionalised due to an official or judicial order? - Does the subject have a positive pregnancy test before the baseline period? - Does the subject use an unacceptable and unreliable contraceptive method during the trial, is pregnant or within the lactation period or is seeking to become pregnant? - Has the subject undergone previous specific immunotherapy with allergens of house dust or storage mites in any formulation? - Is the subject currently undergoing any sort of immunotherapy? - Has the subject ever undergone specific immunotherapy with unknown allergen or an unsuccessful immunotherapy? - Has the subject undergone changes in sanitation actions against house dust mites in the previous 12 months before trial entry or planning changes during the trial? - Has the subject for storage mites like Acarus siro, Lepidoglyphus destructor or Tyrophagus putrescentiae: o Clinically relevant symptoms or o Sensitisation in the SPT: wheal diameter of respective interfering allergen = wheal diameter of D. pter. or o Sensitisation to respective interfering allergen as determined by serum immunoassay = kU/L value of D. pter. - Has the subject for other allergens than D. pter. that interfere with the annual diary periods from October to December: o Clinically relevant symptoms or o Sensitisation in the SPT: wheal diameter of respective interfering allergen =3 mm or o Sensitisation to respective interfering allergen as determined by serum immunoassay >1.5 kU/L. Such other interfering allergens are especially of: ? Cat or dog, ? Moulds like Aspergillus or Penicillium, ? Blatella germanica, ? Parietaria and cypress family (only Spain and Italy) - Does the subject suffer from clinically relevant rhino-conjunctival or respiratory symptoms related to other reasons? - Has the subject a peak expiratory flow (PEF) or FEV1 <80% of predicted normal? - Has the subject uncontrolled or partly controlled asthma according to GINA guidelines? - Has the subject suffered from asthma for more than 10 years? - Has the subject suffered from rhinitis/rhinoconjunctival atopy symptoms for 20 years or longer? - Does the subject suffer from severe acute or chronic diseases, severe inflammatory diseases? - Does the subject suffer from autoimmune diseases, immune-defects including immune-suppression, immune-complex-induced immunopathies? - Does the subject suffer from severe psychiatric and psychological disorders including impairment of cooperation? - Does the subject suffer from recurrent seizures? - Does the subject suffer from irreversible secondary alterations of the reactive organ? - Has the subject any physiological and laboratory variables within/outside normal limits and reported to be greater than Grade 1 changes according to the Food and Drug Administration (FDA) Guidance for In
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 Dermatophagoides pteronyssinus (D. pter.) in adolescents and adults with allergic rhinitis/rhinoconjunctivitis caused by house dust mites with or without controlled allergic asthma. The primary endpoint regarding efficacy is the change in the area under the curve (AUC) of the rhinitis symptom-medication-score (R-SMS) from the baseline period to after 2 years of double-blind treatment. ;Secondary Objective: - Change in the AUC of the R-SMS from the baseline season to the season after 1 year of double-blind treatment. - Immunologic changes: specific immunoglobuline G (IgG1 and IgG4). - Tolerability and safety of treatments during the entire trial period. - Well days based on rhinitis SMS (no medication intake and maximum 2 score points). - Response status in terms of 40% improvement for the primary efficacy variable for an individual trial subject. - Change of EQ-5D (before vs. after treatment). ;Primary end point(s): The primary endpoint of this study is the change in the area under the curve (AUC) of the Rhinitis Symptom-Medication-Score (R-SMS) from the baseline period to after 2 years of double-blind treatment. | — |
Countries
Bulgaria, Poland, Spain
Outcome results
None listed