Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites
Randomized, Double-blinded, Placebo-controlled, Prospective, Multicenter Trial to Evaluate the Efficacy and Safety of SIC in Subjects With Mild/Moderate Asthma and Rhinitis/Rhinoconjunctivitis Sensitized to D.Pteronyssinus and/or D. Farinae
A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with mild to moderate asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.
Double blind, multicenter, parallel placebo controlled study. It includes 150 subjects sensitised to mites, from 14 to 65 years of age. Medication treatment of 1 year. The main outcome: CSMS
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
The same solution and presentation as the active treatment, but without active ingredients.
10,000 TU/mL of subcutaneous immunotherapy
30,000 TU/mL of subcutaneous immunotherapy
The same solution and presentation as the active treatment, but without any active ingredients.
Inclusion Criteria: Written informed consent. Age between 14 and 65, both genders. Positive suggestive clinical history of intermittent or persistent moderate to severe rhinitis /rhinoconjunctivitis, with or without moderate intermittent or persistent asthma, due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent form Subjects with a positive skin prick-test wheal size >5 mm higher diameter due to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae. The positive and negative control of the test should give consistent results Specific immunoglobulin E against house dust mites >3 ku/mL (InmunoCAP® o Immulite), for the complete extract of Dermatophagoides pteronyssinus and / or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources Women of childbearing age (from menarche) must present a urine pregnancy test with a negative result at the time of joining the trial. Women of childbearing age participating in the trial must agree to use an appropriate method of contraception, meaning any act, device, or medication to prevent conception or viable pregnancy, during the trial if they are sexually active. Subjects with a diagnosis of asthmatic pathology made by means of a bronchodilator test or subjects with a previous diagnosis of asthma according to the GEMA 5.0 guideline due to clinical history. Subjects capable of complying with the dosing regimen. Subjects who own an smartphone for symptom registration and medication Exclusion Criteria: Subjects outside of the age range. Subjects polysensitized to other aeroallergens in addition to Dermatophagoides pteronyssinus and Dermatophagoides farinae, except for epithelia with exposure and occasional symptoms. Subjects who have received prior immunotherapy in the preceding 5 years for any of the allergens tested or an allergen with cross-reactivity or are currently receiving immunotherapy with any allergen. Subjects in which 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. Subjects have not granted written informed consent. Subjects with severe or uncontrolled intermittent or persistent asthma, with an FEV1 <70% with respect to the reference value despite adequate pharmacological treatment at the time of inclusion in the trial. Likewise, subjects with intermittent or persistent rhinitis / rhinoconjunctivitis with severe symptoms in which the suspension of oral or systemic antihistamine treatment is contraindicated. Subjects who required oral corticosteroids in the 12 weeks prior to enrollment in the trial. Subjects who have previously presented a serious secondary reaction during the performance 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 asthma exacerbation, respiratory infection, feverish process, acute urticaria, etc.). Subjects with active chronic urticaria, severe dermography, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests are performed, or a history of hereditary angioedema. Subjects that have some pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.). Subjects with some other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor disorder, uncontrolled diabetes, malformations, multiple operations, kidney disease,). Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumor diseases or with a diagnosis of immunodeficiencies. Subject whose status prevents him from offering cooperation and or who has severe psychiatric disorders. Subjects with a known allergy to other components of the investigational medicinal product other than the allergen. Subjects with diseases of the lower respiratory tract other than asthma such as emphysema or bronchiectasis. Direct investigator's relatives. Pregnant or women at risk of pregnancy and breastfeeding women.