Efficacy and Safety Evaluation for the Treatment of Allergy Against Grass and Olive Pollen

Inclusion Criteria:

1. Subject who has signed the informed consent.

2. Subjects of both sexes aged between 12 and 65 years.

3. Subjects with confirmed clinical history of inhalational allergy (rhinitis and / ormoderate-severe intermittent or persistent rhinoconjunctivitis according to the ARIAclassification with or without intermittent or persistent controlled mild-moderateasthma according to the GEMA 5.0 classification caused by grass and olive allergy.The diagnosis of asthma will be valid from 12 months prior to signing the informedconsent

4. Subjects with a positive prick test (higher papule diameter ≥ 5 mm) to astandardized extract of pollen from grasses (Phleum pratense, Holcus lanatus,Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or one of thecomponents of the mixture and an olive extract.

5. Specific IgE (CAP or Immulite) against a mixture of grasses or against one of thecomponents of the mixture of grasses, preferably Phleum pratense and olive or one ofthe molecular components of allergenic sources with a value > 3,5 KU / L.

6. Women of childbearing age (from menarche) should submit a urine pregnancy test witha negative result at the time of joining the trial.

7. Women of childbearing potential, and men participating in the trial, should committo using an appropriate method of contraception. Medically acceptable methods ofcontraception are intrauterine devices placed at least 3 months in advance, surgicalsterilization (for example, tubal ligation), barrier methods, or the use of oralcontraceptives.

8. Subjects capable of complying with the dosage regimen.

9. Subjects who have a smartphone to record symptoms and medication.

10. Subjects with a negative prick test to coestational pollens. In the case specificIgE is available, the result should be <3,5 kU/L and without relevant symptomatology

11. Subjects with a negative prick test to other aeroallergens (dust mites, epitheliumsand fungus). In the case specific IgE is available, the result should be <3,5 kU/Land without relevant symptomatology

Exclusion Criteria:

1. Subjects polysensitized to other aeroallergens with the exception of epithelia withoccasional exposure and symptoms

2. Subjects polysensitized to other aeroallergens with the exception non-seasonalpollens with grasses and olive

3. Subjects who have received prior immunotherapy in the preceding 5 years to anyaeroallergens.

4. Subjects in which 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.

5. Subjects with severe or uncontrolled persistent asthma, with an FEV1 <70% withrespect to the reference value despite adequate pharmacological treatment at thetime of inclusion in the trial. Likewise, subjects with intermittent or persistentrhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oralor systemic antihistamine treatment is contraindicated.

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

7. Subjects under treatment with ß-blockers.

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

9. Subjects with active chronic urticaria, severe dermographism, severe atopicdermatitis, sunburns, active psoriasis with lesions in areas where skin tests willbe performed, or a history of hereditary angioedema.

10. Subjects who have any pathology in which the administration of adrenaline iscontraindicated (hyperthyroidism, HT, heart disease, etc.).

11. Subjects with some other disease not related to moderate rhinoconjunctivitis orasthma, but of potential severity and that may interfere with treatment andfollow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations,multiple operations, kidney disease,).

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

13. Subject whose condition prevents him / her from offering cooperation and who hassevere psychiatric disorders.

14. Subjects with a known allergy to other investigational drug components other thanthe allergen.

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

16. Subjects who are direct relatives of the researchers.

17. Pregnant or lactating women.