Prospective, Randomised, DBPC, Double-dummy, Multicenter CT of Efficacy and Safety With IT in Patients With Controlled Mild to Moderate Allergic Asthma and Rhinitis/Rhinoconjunctivitis, Allergic to D. Pteronyssinus and/or D. Farinae.

MM09-SIT-040

Prospective, randomized, placebo-controlled, multicenter of 3 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with mild to moderate asthma and rhinitis/rhinoconjunctivitis (intermittent or persistent) allergic to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.

2022-12-01

2024-07-01

2025-07-01

Not yet recruiting

Early phase I

400

Inclusion Criteria: 1. Signed and dated Informed Consent Form (ICF). 2. Female or male aged 12 to 60 years, both included. 3. Confirmed clinical history of inhalation allergy (mild-moderate controlled intermittent or persistent asthma according to the definition of GEMA 5.0 and GINA 2020 and intermittent or persistent rhinitis / rhinoconjunctivitis according to the ARIA classification, caused by Dermatophagoides pteronyssinus and / or Dermatophagoides farinae). The asthma diagnosis will be valid up to 24 months prior to signing the informed consent. 4. Positive skin prick test (wheal major diameter ≥ 5 mm) to a standardized allergen extract of Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. 5. Specific IgE against a complete extract of D. pteronyssinus and/or D. farinae or any of the molecular components of allergenic sources with a value ≥ 3.5 kU/L. 6. Women of childbearing age must have a urine pregnancy test negative result before enrolling the study. 7. Women of childbearing age must commit to using an adequate contraception method. 8. Capable of complying with dosage regimen. 9. Owning a smartphone to register symptoms and medication consumption. 10. A negative skin prick test to other aeroallergens with specific IgE \< 3.5 kU/L with no clinical relevance. Exclusion Criteria: 1. Previous immunotherapy to any of the tested allergen during the last 5 years or any desensitization process in the last 2 years (ITO, milk, egg, ...) or currently receiving immunotherapy with any other allergen. 2. Positive skin prick test to other aeroallergens, except for intermittent symptoms due to temporary exposition to dander. 3. Those cases in which AIT would be a contraindication according to the criteria of European Allergy and Clinical Immunology Immunotherapy Subcommittee. 4. Uncontrolled or severe asthma and/or FEV1 \<70% despite pharmacological treatment by the time of enrolment. 5. Intake of β-blockers. 6. Use of immunosuppressive or biological drug. 7. Unstable patients by the time of enrolment (acute exacerbation asthma, respiratory infection, fever, acute pruritus, etc). 8. Patients who have suffered chronic urticaria during the last 2 years, severe anaphylaxis, or family history of angioedema. 9. Having any contraindication for the use of adrenaline (hyperthyroidism, heart disease, high blood pressure). 10. Other severe diseases not related to allergic asthma or rhinitis that could interfere in the study treatment or the follow-up (epilepsy, psychomotor agitation, diabetes, malformations, nephropathy) according to medical criteria. 11. Autoimmune diseases (thyroiditis, lupus, etc.), tumoral diseases or immunodeficiencies. 12. Participants that the investigator believes could not comply with the study protocol or have serious psychiatric disorders. 13. Known allergy to any of the ingredients of the study medication except for mites. 14. Lower respiratory tract diseases different from asthma as bronchiectasis or chronic obstructive pulmonary disease. 15. Breast-feeding or pregnant women. 16. Being immediate family of the investigator. 17. Concurrent participation in other clinical trials or prior participation within 30 days prior to inclusion. 18. History of serious systemic reactions, including food, Hymenoptera venom, medications, etc.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, placebo-controlled, double-blind, double-dummy, multi-center trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': 'During the trial, both the investigator and the included subjects will be unaware of the treatment each subject is receiving.\n\nThe person in charge of data analysis will also not know the treatment assigned to each subject until the database has been closed.\n\nNeither the subject nor the investigator knows what treatment each subject is receiving, all the trial medication is identical in terms of outer packaging and appearance.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2022-11-18