Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

Inclusion Criteria:

• Written informed consent.

• Age between 12 and 65, both genders.

• Subjects with a confirmed clinical history of inhalant allergy (intermittent orpersistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIAclassification with or without intermittent or persistent mild-moderate controlledasthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoidespteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be validfrom 12 months prior to signing the informed consent.

• Subjects with a positive skin prick-test wheal size >5 mm higher diameter due toDermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive andnegative control of the test should give consistent results. The results will bevalid 12 months prior to the signing of the informed consent.

• Specific immunoglobulin E against house dust mites >3,5 KU/mL (InmunoCAP® oImmulite), for the complete extract of Dermatophagoides pteronyssinus and / or forDermatophagoides farinae or for some of the molecular components of these allergenicsources

• Subjects should preferably be monosensitized to the study allergens. In case ofsubjects sensitized to other aeroallergens, only those with the followingcharacteristics may be included in the study:

• Subjects with positive skin test to Blomia tropicalis and Lepidoglyphusdestructor, whose specific IgE values do not exceed or equal the values for thestudy allergens. The maximum specific IgE value for these allergens is 3.5KU/L.

• Subjects with positive skin tests to epithelia, as long as they presentoccasional exposure and symptomatology.

• Subjects with positive skin tests to pollens, whose specific IgE values do notexceed or equal the values of the allergens in the study and who do not presentexacerbations during the pollen season. The maximum value of specific IgE forthese allergens is 17.5 KU/L.

• Subjects with negative skin test for fungi

• Women of childbearing age (from menarche) must present a urine pregnancy test with anegative result at the time of joining the trial, before the first administration ofthe IMP.

• Women of childbearing age participating in the trial must agree to use anappropriate method of contraception, meaning any act, device, or medication toprevent conception or viable pregnancy, during the trial if they are sexuallyactive.

• Subjects with a diagnosis of asthma according to the GEMA 5.0 guideline.

• Subjects capable of complying with the dosing regimen.

• Subjects who own an smartphone for symptom registration and medication

Exclusion Criteria:

• Subjects who have received previous immunotherapy in the previous 5 years to dander,fungi, and mites.

• Subjects in whom immunotherapy may be subject to an absolute generalcontraindication according to the criteria of the Immunotherapy Committee of theSpanish Society of Allergy and Clinical Immunology and the European Allergy andClinical Immunology Immunotherapy Subcommittee.

• Subjects with persistent severe or uncontrolled asthma, with an FEV1<70% of baselinedespite adequate pharmacological treatment at the time of inclusion in the trial.Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis withsevere symptoms in whom oral or systemic antihistamine therapy is contraindicated.

• Subjects who have previously presented a serious secondary reaction during theperformance of diagnostic skin tests using the prick test.

• Subjects under treatment with β-blockers.

• Clinically unstable subjects at the time of inclusion in the trial (acute asthmaexacerbation, respiratory infection, feverish process, acute urticaria, etc.).

• Subjects with chronic active urticaria, severe dermographism, severe atopicdermatitis, sunburn, active psoriasis with lesions in areas where skin prick testwill be performed, or a history of hereditary angioedema.

• Subjects with any other disease not related to moderate rhinoconjunctivitis orasthma, but of potential severity and that may interfere with treatment andfollow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations,multiple surgeries, nephropathy).

• Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or witha diagnosis of immunodeficiencies.

• Subject whose condition prevents him/her from offering cooperation and/or who hasserious mental illness.

• Subjects with a known allergy to other components of the investigational medicinalproduct other than the allergen.

• Subjects with diseases of the lower respiratory tract other than asthma such asemphysema or bronchiectasis.

• Direct investigator's relatives.

• Pregnant women or breastfeeding women.