Efficacy and Safety Evaluation for the Treatment of Asthma and Allergic Rhinitis/Rhinoconjunctivitis

Inclusion Criteria:

1. Subjects who have signed the informed consent
2. Subjects with a confirmed medical history of asthma (intermittent or persistentmild-moderate, controlled), as defined by GEMA 5 with moderate-severe rhinitis /rhinoconjunctivitis (intermittent or persistent) according to the ARIA classificationcaused by polysensitization to grass pollen and mites (D. pteronyssinus and / or D.farinae). The diagnosis of asthma will be valid from 24 months prior to signing theinformed consent.
3. Subjects with a positive prick test (major diameter of the papule ≥ to 5 mm) to astandardized extract of grass pollen mixture, or to one of the components of themixture (Dactilys glomerata, Poa pratensis, Holcus lanatus, Festuca elatior, Phleumpratense and Lolium perenne) and to an extract of D. pteronyssinus and / or D.farinae. Results will be valid 12 months prior to signing the informed consent.
4. Specific IgE (CAP or Immulite) against one of the components of the mixture ofgrasses, preferably Phleum pratense or a mixture of grasses and mites (D.pteronyssinus and / or D. farinae) or one or more of the molecular components ofallergenic sources with a value > 3,5 KU / L. Results will be valid 12 months prior tosigning the informed consent.
5. Subjects will preferably be sensitive to study allergens (Dermatophagoides andgrasses). In the case of subjects sensitized to other aeroallergens, only those withthe following characteristics (results valid up to 12 months prior to signing of theinformed consent) can be included in the study:
6. Subjects with a positive prick test for Blomia tropicalis and Lepidoglyphusdestructor, whose maximum values of specific IgE are 3.5 KU/L and do not exceedor equal the values of the allergens of the study (Dermatophagoides and grasses).
7. Subjects with a negative prick test to epithelium, whose specific IgE values are < 0.35 KU/L. Subjects with occasional exposure and symptomatology to epitheliummay be included with a positive prick test regardless of the value of thespecific IgE.
8. Subjects with a positive prick test for non-coestational pollens, whose maximumvalues of specific IgE are 17.5 KU / L and do not exceed or equal the values ofthe allergens of the study (Dermathophagoids and grasses) and who also do notpresent exacerbations in the pollen season.
9. Subjects with a negative prick test for fungi. If the specific IgE determination hasbeen made, the result shall be < 0,35 KU/L.
10. Subjects with a negative prick test for coestacional pollens with grasses. If thespecific IgE determination has been made, the result shall be < 0,35 KU/L.
11. Subjects aged between 12 and 65 years, inclusive.
12. Subjects capable of complying with the dosing regimen.
13. Women of childbearing age (from menarche) should submit a urine pregnancy test with anegative result at the time of enrolment in the trial.
14. Women of childbearing potential should commit to using an adequate method ofcontraception. Medically acceptable methods of contraception are intrauterine devicesplaced at least 3 months in advance, surgical sterilization (for example, tuballigation), barrier methods, or the use of oral contraceptives.
15. Subjects who have a smartphone to record symptoms and medication.

Exclusion Criteria:

1. Subjects who have received prior immunotherapy treatment in the preceding 5 years forany aeroallergen.
2. Patients in whom immunotherapy may be the object of 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 cannot be included.
3. Subjects with severe or uncontrolled asthma, and / or with a FEV1 <70% with respect tothe reference value despite adequate pharmacological treatment at the time ofinclusion in the trial.
4. Subjects who have previously presented a serious secondary reaction during theperformance of diagnostic skin tests using the prick test.
5. Subjects under treatment with ß-blockers.
6. Subjects under treatment with immunosuppressive or biological drugs.
7. Clinically unstable subjects at the time of inclusion in the trial (respiratoryinfection, feverish process, acute urticaria, etc.).
8. Subjects with chronic urticaria in the past 2 years, severe anaphylaxis, or a historyof hereditary angioedema.
9. Subjects who have any pathology in which the administration of adrenaline iscontraindicated (hyperthyroidism, HT, heart disease, etc.).
10. Subjects with some other disease not related to moderate rhinoconjunctivitis orasthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, diabetes, malformations, subjects who underwentmultiple surgeries, kidney disease...), according to investigator's criteria.
11. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or with adiagnosis of immunodeficiencies.
12. Subject whose condition prevents him / her from offering cooperation and or whoresents severe psychiatric disorders, according to investigator criteria.
13. Subjects with known allergies to other investigational product components other thangrass pollen or mites.
14. Subjects with diseases of the lower respiratory tract other than asthma such asemphysema or bronchiectasis.
15. Pregnant or lactating women.