E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mites allergy |
Alergía frente a los acaros Dermatophagoides pteronyssinus y Dermatophagoides farinae |
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E.1.1.1 | Medical condition in easily understood language |
Mites allergy |
Alergía frente a los acaros Dermatophagoides pteronyssinus y Dermatophagoides farinae |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020419 |
E.1.2 | Term | House dust mite allergy |
E.1.2 | System Organ Class | 100000004870 |
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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 |
Establish a dose-response relationship for the treatment of rhinitis/rhinoconjunctivitis due to mites allergy treatment sublingual therapy. |
El objetivo principal de este ensayo consiste en la determinación de la dosis más eficaz para el tratamiento de rinitisrinoconjuntivitis por alergia a los ácaros Dermatophagoides pteronyssinus y Dermatophagoides farinae, mediante el test de provocación nasal (TPN), tanto para el tratamiento subcutáneo como para el tratamiento sublingual. |
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E.2.2 | Secondary objectives of the trial |
As secondary objectives will be assessed the efficacy, tolerance and safety of four concentrations for both immunotherapy subcutaneous and sublingual immunotherapy. The influence of treatment on the following parameters were also assessed: - Dose response skin prick test -Evolution of symptoms - Medication consumption - Quality of life |
Como objetivos secundarios se evaluarán la eficacia, la tolerancia y la seguridad de las cuatro concentraciones tanto para la inmunoterapia subcutánea como para inmunoterapia sublingual. También se evaluará la influencia del tratamiento sobre los siguientes parámetros: - Prick test dosis respuesta -Evolución de síntomas - Consumo de medicación - Calidad de vida |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Written informed consent - Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate asthma, due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae - Subjects with a positive skin prick-test (wheal sixe >6 mm diameter) to a Dermatophagoides pteronyssinus and/or Dermatophagoides farinae allergen extract - Specific IgE against house dust mites >10 kU/L and and whose determination does not exceed 6 months prior to the inclusion visit - Age between 12 and 65 years - Both genders - Subjects capable of giving informed consent - Subjects capable of complying with the dosing regimen - Subjects that have not received immunotherapy against mites in the last 5 years - Subjects submitting sensitization to other aeroallergens, but is considered clinically irrelevant or without clinical interference with the nasal provocation test. |
- Sujeto que haya firmado el consentimiento informado - Sujetos con historia clínica confirmada de alergia inhalatoria (rinitis y/o rinoconjuntivitis intermitente o persistente moderada-grave con o sin asma leve-moderada) causada por alergia a Dermatophagoides pteronyssinus y/o Dermatophagoides farinae - Sujetos con un prick-test positivo (diámetro medio de la pápula > 6 mm) con un extracto de Dermatophagoides pteronyssinus y/o Dermatophagoides farinae. - IgE específica (CAP) frente a ácaros con un valor > 10 KU/L y cuya determinación no supere los 6 meses anteriores a la visita de inclusión. - Sujetos con edad comprendida entre 12 y 65 años - Ambos sexos - Sujetos capaces de otorgar el consentimiento informado - Sujetos capaces de cumplir con el régimen de dosificación - Sujetos que no hayan recibido inmunoterapia frente a ácaros en los últimos 5 años - Sujetos que presenten sensibilización a otros aeroalérgenos pero que sea considerada como clínicamente no relevante o sin interferencia clínica en los momentos de la realización del test de provocación nasal. |
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E.4 | Principal exclusion criteria |
- Subjects outside of the age range. - Subjects who have previously received immunotherapy for the treatment of the allergic rhinitis/rhinoconjunctivitis due to mites and other allergens in the last 5 years. - Subjects that immunotherapy may be an absolute contraindication according to the criteria of the immunotherapy Committee of the Spanish society of Allergy and Clinical Immunology, and of the European Allergy and Clinical Immunology Immunotherapy Subcommittee may also include. - Subjects with important symptoms of rhinoconjunctivitis in which the suspension of the systemic antihistamine treatment is contraindicated. - Subjects with persistent severe or not controlled asthma, with a FEV< 70 respect to the reference value in spite of the appropriate pharmacological treatment at the time of the inclusion in the trial. - Subjects that have required oral corticosteroids in the 12 weeks previous to the inclusion in the trial. - Subjects who receive or have received omalizumab - Subjects who can not stop treatment with intranasal corticosteroids - Subjects with persistent asthma treated with inhaled intranasal corticosteroids - Subjects treated with angiotensin converting enzyme inhibitors ( ACEIs ) - Subjects that have some pathology (hyperthyroidism, hypertension, heart disease, etc.) in which immunotherapy is contraindicated. - Subjects in treatment with beta blockers. - Subjects that have previously submitted a serious secondary reaction during the skin prick test - Subject with active chronic urticaria in the last 2 years - Subjects with hereditary angioedema. - Subjects with any other disease not associated with the rhinitis/rhinoconjunctivitis, but of potential severity and that could interfere with treatment and follow-up (epilepsy, psychomotor deterioration, malformations, kidney diseases,...). - Subjects with tumor diseases - Subject diagnosed or diagnosed with immunodeficiencies - Subjects with chronic sinusitis - Subjects with acute otitis media - Subjects with active positive dermographism - Subjects with structural alterations of the nasal fossa ( polyps , deviated septum, turbinate hypertrophy, not alterable nasal obstruction, nasal vasoconstriction , etc - Subject whose status prevents him from providing cooperation and or which present severe psychiatric disorders. - Subject with known allergy to other components of the vaccine different from mites allergen extract. - Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis. - Direct investigator's relatives - Pregnant or women at risk of pregnancy and breastfeeding women. |
- Sujetos fuera del rango de edad. - Sujetos que hayan recibido previamente inmunoterapia para el tratamiento de la rinitis/rinoconjuntivitis o asma alérgicas en los últimos 5 años. - Sujetos con síntomas importantes de rinoconjuntivitis en los cuales la suspensión del tratamiento antihistamínico por vía sistémica esté contraindicada. - Sujetos con asma persistente grave o no controlada, con un FEV1 <70% con respecto al valor de referencia a pesar del un tratamiento farmacológico adecuado en el momento de la inclusión en el ensayo. - Sujetos que hayan requerido corticoides orales en las 12 semanas previas al momento de la inclusión en el ensayo. - Sujetos que reciben o hayan recibido omalizumab - Sujetos que no puedan suspender el tratamiento con corticoides intranasales - Sujetos con asma persistente en tratamiento con corticoides intranasales inhalados - Sujetos en tratamiento con inhibidores de la enzima convertidora de angiotensina (IECAs) - Sujetos que tengan alguna patología en la que esté contraindicada la administración de adrenalina (hipertiroidismo, HTA no controlada, cardiopatía, etc.). -Sujetos en tratamiento con ß-bloqueantes. - Sujetos que hayan presentado previamente una reacción secundaria grave durante la realización de pruebas cutáneas de diagnóstico mediante prick test. - Sujetos inestables desde el punto de vista clínico en el momento de la inclusión en el ensayo (infección respiratoria, proceso febril, urticaria aguda, etc.) - Sujetos con urticaria crónica activa durante los 2 últimos años - Sujetos con antecedentes de angioedema hereditario. - Sujetos con alguna otra enfermedad no relacionada con la rinitis/rinoconjuntivitis, pero de potencial gravedad y que pueda interferir con el tratamiento y seguimiento (epilepsia, alteración psicomotora, malformaciones, multioperados, nefropatías,..). - Sujetos con enfermedad autoinmune (tiroiditis, lupus, etc.) - Sujetos con enfermedades tumorales - Sujeto diagnosticado de inmunodeficiencia. - Sujetos con sinusitis crónica - Sujetos con otitis media aguda - Sujetos con dermografismo positivo activo - Sujetos con alteraciones estructurales de las fosa nasales (poliposis, desviación del septo, hipertrofia de los cornetes, obstrucción nasal no modificable, con vasoconstricciones nasal, etc - Sujeto cuyo estado le impide ofrecer cooperación y o que presente trastornos psiquiátricos severos. - Sujetos con alergia conocidas a los otros componentes de la vacuna diferentes al extracto de ácaros - Sujetos con enfermedades de la vía respiratoria inferior diferentes al asma como el enfisema o las bronquiectasias. - Sujetos que sean familiares directos de los investigadores. - Mujeres embarazadas o con riesgo de embarazo y mujeres lactantes |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change of the threshold concentration necessary to cause a reaction positive after the test of nasal provocation (TPN) between the start and the end of the trial, by acoustic rhinometry. |
Cambio de la concentración umbral necesaria para provocar una reacción positiva después del test de provocación nasal (TPN) entre el inicio y el final del ensayo, mediante rinometría acústica. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Begining and end of the clinical trial |
Principio y final del ensayo |
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E.5.2 | Secondary end point(s) |
- Dose finding skin prick test - Safety variables -Symptoms and concomitant medication consumption -Quality of life -Immunological parameters |
-Test cutáneos dosis-respuesta -Síntomas y consumo de medicación concomitante -Calidad de vida -Parámetros inmunológicos |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Begining and end of the clinical trial |
Principio y final del ensayo |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
Doble simulación |
Double dummy |
|
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.8.2.4 | Number of treatment arms in the trial | 9 |
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 | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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The trial will finishe with the closed out of the data base |
El ensayo finalizará con el cierre de la base de datos de los resultados del ensayo. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |