E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039085 |
E.1.2 | Term | Rhinitis allergic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001705 |
E.1.2 | Term | Allergic asthma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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.
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E.2.2 | Secondary objectives of the trial |
- 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).
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 <3 mm and o EAST result ≥1.5 kU/L to D. pter. (central laboratory) and o Main discomfort in the months October to December or over the entire year on exposure to house dust mites and o Treated with anti-allergic medications for at least 2 years before enrolment.
At the Beginning of the Treatment Period (March 2011): 5. Does the subject have proven exposure to house dust mites demonstrated by positive house dust mite allergen determination in bed/upholstered furniture of the subject’s living area? 6. Has the subject demonstrated adequate symptoms in the subject diary?
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E.4 | Principal 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 Industry and/or normal for population? - Is the subject treated with beta-blockers (locally and systemically)? - Has the subject any contraindication for use of adrenalin? - Has the subject completed or have an ongoing treatment with anti IgE antibody? - Has the subject ongoing long-term treatment with tranquilizers or other psychoactive drugs? - Is the subject treated for allergy according to severity of symptoms with other than the following medications during the assessment period: levocabastine nasal spray (0.5 mg/mL), loratadine/cetirizine tablets (10 mg), and oxymetazoline spray (0.05%)? (Unchanged basic treatment with inhaled corticosteroids up to a dose of 500 µg beclomethasone di propionate [BDP]/-equivalent and the use of salbutamol as needed is permitted in asthmatics.) - Is the subject using any prophylactic and any treatment with antiallergic medication in fixed (constant) dosage during the treatment phase of the trial?
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 49 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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End of open-label treatment period |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |