Resumen

Ensayo clínico prospectivo, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad del extracto alergénico de Dermatophagoides polimerizado y conjugado con manano para el tratamiento de la rinitis/rinoconjuntivitis alérgica con o sin asma. El objetivo principal del ensayo clínico es evaluar la eficacia clínica del producto medicinal en investigación administrado por vía sublingual, en comparación con el placebo, para el tratamiento de la rinitis/rinoconjuntivitis moderada-grave con o sin asma intermitente o persistente leve a moderada controlada, utilizando la puntuación combinada de síntomas y medicación de rinitis/rinoconjuntivitis (R-CSMS por sus siglas en inglés).

Descripción detallada

Se ha demostrado que la inmunoterapia alergeno-específica (ITA) es eficaz para aliviar síntomas, reducir el uso de medicación y mejorar la calidad de vida en pacientes con alergias respiratorias. Se considera que esto se debe a la inducción de un estado de tolerancia a alergenos específicos con efectos duraderos tras la interrupción del tratamiento. Está aceptado que la inmunoterapia es el único método disponible para que los alergólogos mejoren o curen, parcial o definitivamente, un proceso alérgico. La población del estudio de este ensayo clínico comprenderá sujetos alérgicos a ácaros (Dermatophagoides pteronyssinus y/o D. farinae) con síntomas de rinitis/rinoconjuntivitis moderada-grave con o sin asma leve a grave controlada, aptos para inmunoterapia alergénica. El criterio de valoración primario de eficacia será la puntuación combinada de síntomas y medicación de rinitis/rinoconjuntivitis. Cada día, desde el inicio de la administración del fármaco en investigación (V2-VF), se pedirá al sujeto que puntúe y registre sus síntomas y anote el consumo de medicación en un diario electrónico, siguiendo las instrucciones de la aplicación. Este diario proporcionará la puntuación de síntomas y el consumo de medicación de cada sujeto durante el ensayo.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 60 YearsSexo: ALL

Criterios de inclusión

Signed Informed Consent Form.
Male or female, aged between 12 and 60 years, both included.
Confirmed clinical history of inhalation allergy with moderate-severe rhinitis/rhinoconjunctivitis according to the ARIA classification with or without controlled mild-moderate intermittent or persistent asthma according to the definition of GEMA 5.0 y GINA caused by allergy to mites (D. pteronyssinus and/or D. farinae). The asthma diagnostic will be valid up to 24 months prior to signing the informed consent form.
Combined Symptom and Medication Score for moderate to severe rhinitis/rhinoconjunctivitis (RCSMS) ≥ 1,8 out of 3.
Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The results will be valid up to 12 months prior to signing the informed consent form.
Specific IgE against a complete extract of Dermatophagoides pteronyssinus and/or D. farinae or any the molecular components of allergenic sources with a value ≥ 3.5 kU/L. The results will be valid up to 12 months prior to signing the informed consent form.
Subjects shall preferably be monosensitised to the study allergens. In case of subjects sensitised to other aeroallergens, only those with the following characteristics may be included in the study (results will be valid up to 12 months prior to signing the informed consent form):
Subjects with a positive skin prick test to Blomia tropicalis and Lepidoglyphus destructor, whose wheal major diameter and specific IgE values do not exceed or equal the values for the study allergens.
Subjects with a positive skin prick test for dander if they have occasional exposure and symptoms.
Subjects with positive skin prick test to pollens, whose specific IgE values do not exceed or equal the values for the study allergens and who also do not have exacerbations during pollen season. The maximum specific IgE value to theses allergens is 17.5 kU/L.
Subjects with negative skin prick test to mold. In case specific IgE determination have been performed, the result must be \<0.35 kU/L.
Women of childbearing age (since menarche) must present a negative urine pregnancy test at the time of trial enrollment.
Women of childbearing age must commit to using and adequate contraception method.
Subjects capable of complying with a dosage regimen.
Subjects owning a smartphone to register symptoms and medication consumption.

Criterios de exclusión

Subjects polysensitized to other aeroallergens with clinically relevant symptoms.
Subjects who have received previous immunotherapy in the preceding 5 years to any of the tested allergens or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
Patients in whom immunotherapy may be subject to an absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee may not be included.
Subjects with uncontrolled severe asthma, and/or with FEV1 \<80% of baseline despite adequate pharmacological treatment by the time of the enrolment.
Subjects on treatment with ß-blockers.
Subjects on treatment with immunosuppressive or biological drugs.
Subjects who are unstable by the time of enrolment (respiratory infection, febrile process, acute pruritus, etc.).
Subjects with chronic urticaria during the last 2 years, severe anaphylaxis or with hereditary angioedema history.
Subjects with any pathology in which the administration of adrenaline is contraindicating (hyperthyroidism, hypertension, heart disease, etc.) according to the investigator discretion.
Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and that could interfere with treatment and follow-up (epilepsy, psychomotor disorders, diabetes, malformations, multi-surgery, nephropathy, etc.), according to the investigator discretion.
Subjects with severe autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
Subject whose condition prevents him/her from offering cooperation and/or who presents severe psychiatric disorders, according to the investigator discretion.
Subjects with known allergy to the other components of the investigational product other than allergen study.
Subjects with lower airway diseases other than asthma such as emphysema or bronchiectasis.
Pregnant or breastfeeding women.
Subjects who are immediate family members of researchers.
Concurrent participation in other clinical trials or previous participation within 30 days prior to inclusion.
History of severe systemic reactions, including food, hymenoptera venom, etc.
Subjects who have suffered a respiratory tract infection and/or asthma exacerbation within 4 weeks prior to screening.
Subjects with a history of significant renal disease or chronic liver disease.

Intervenciones

biological

3,000 MM09

Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 3.000 UTm/mL for sublingual immunotherapy.

biological

9,000 MM09

Allergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 9.000 UTm/mL for sublingual immunotherapy.

other

Placebo sublingual

The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.

Ensayo clínico prospectivo, aleatorizado, doble ciego, controlado con placebo (ECDBCP) para evaluar la eficacia y la seguridad del extracto alergénico de Dermatophagoides polimerizado y conjugado con manano para el tratamiento de la rinitis/rinoconjuntivitis alérgica con o sin asma

Resumen

Descripción detallada

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

3,000 MM09

9,000 MM09

Placebo sublingual

Ubicaciones

Fundación CIDEA

Patrocinadores

Contactos

Miguel Casanovas, MD, PhD