Prospective, randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of polymerized and mannan conjugated allergen extract of Dermatophagoides for the treatment of allergic rhinitis/rhinoconjunctivitis with or without asthma.
The main objective of the clinical trial is to evaluate the clinical efficacy of the investigational medicinal product, administered sublingually, compared to placebo for the treatment of moderate-severe rhinitis/rhinoconjunctivitis with or without mild to moderate asthma and controlled using the Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score (R-CSMS).
Signed Informed Consent Form.
Male or female, aged between 12 and 60 years, both included.
Confirmed clinical history of inhalation allergy with moderate-severe rhinitis/rhinoconjunctivitis according to the ARIA classification with or without controlled mild-moderate intermittent or persistent asthma according to the definition of GEMA 5.0 y GINA caused by allergy to mites (D. pteronyssinus and/or D. farinae). The asthma diagnostic will be valid up to 24 months prior to signing the informed consent form.
Combined Symptom and Medication Score for moderate to severe rhinitis/rhinoconjunctivitis (RCSMS) ≥ 1,8 out of 3.
Subjects polysensitized to other aeroallergens with clinically relevant symptoms.
Subjects who have received previous immunotherapy in the preceding 5 years to any of the tested allergens or a cross-reactive allergen or are currently receiving immunotherapy with any allergen.
Patients in whom 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 may not be included.
Subjects with uncontrolled severe asthma, and/or with FEV1 <80% of baseline despite adequate pharmacological treatment by the time of the enrolment.
Parallel
3,000 MM09
Biological/VaccineAllergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 3.000 UTm/mL for sublingual immunotherapy.
9,000 MM09
Biological/VaccineAllergoid (Dermatophagoides pteronyssinus and Dermatophagoides farinae)-mannan conjugates (MM09) at 9.000 UTm/mL for sublingual immunotherapy.
Placebo sublingual
Other interventionThe same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
Rhinitis/rhinoconjunctivitis Combined Symptom and Medication Score (RCSMS)
Assessment of the number of rhinitis/rhinoconjunctivitis symptoms and medication consumption required to control these symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. Rhinitis/Rhinoconjunctivitis Combined Symptom and Medication Score will be based on the work done by Pfaar et al. The score for each rhinitis/rhinoconjunctivitis symptom will be 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score = 0-3 The score for Rhinitis/rhinoconjunctivitis medication will be: 0 = No medication; 1 = Oral or topical (eye or nose) non-sedating H1 antihistamines (H1A); 2 = Intranasal corticosteroids (INS) with/without H1A; 3 = Oral corticosteroids with/without (INS), with/without H1A. Total daily medication score = 0-3
Rhinitis/ Rhinoconjunctivitis Symptom Score (RSS)
Assessment of the number of rhinitis/rhinoconjunctivitis symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for each rhinitis/rhinoconjunctivitis symptom will be 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score = 0-3
Rhinitis/Rhinoconjunctivitis Medication Score (RMS)
Evaluation of the medication consumption required to control the rhinitis/rhinoconjunctivitis symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for rhinitis/rhinoconjunctivitis medication will be: 0 = No medication; 1 = Oral or topical (eye or nose) non-sedating H1 antihistamines (H1A); 2 = Intranasal corticosteroids (INS) with/without H1A; 3 = Oral corticosteroids with/without (INS), with/without H1A. Total daily medication score = 0-3
Asthma Combined Symptom and Medication Score (ACSMS)
Evaluation of the number of asthma symptoms and medication consumption required to control these symptoms for each subject during the trial, for each group compared to the others, and compared to placebo. The score for each asthma symptom will be: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score = 0-3 The asthma medication will be scored based on the therapeutic step in which the drugs are included in the Guía Española para el Manejo del Asma (GEMA) 5.0 and Global Initiative for Asthma (GINA) 2020 guidelines. The scoring method is detailed in the article entitled "Combination of Allergic Asthma Symptom and Medication Scores in Allergen Immunotherapy Trials: A Proposal". Total daily medication score (ACSMS) = 0-3
Asthma Symptom Score (ASS)
Assessment of the number of asthma symptoms of each subject during the trial, for each group compared to the others, and compared to placebo. The score for each asthma symptom will be: 0 = No symptoms; 1 = Mild; 2 = Moderate; 3 = Severe. Total daily symptom score (ASS) = 0-3
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