2026-04-13T15:15:32Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/138702025-10-24T10:40:05Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Matas-Ros, María author Roger, Albert author Tabar, Ana I author Buendia, Inmaculada author Garriga Baraut, Teresa author 2025-10-16T06:33:59Z 2025-10-16T06:33:59Z 2025-05-28 Dust mite allergy; Immunologic desensitization; Vaccines Al·lèrgia als àcars de la pols; Dessensibilització immunològica; Vacunes Alergia a los ácaros del polvo; Desensibilización inmunológica; Vacunas Background There is an important heterogeneity of the clinical research done to date for allergen immunotherapy (AIT). We plan to assess the safety and efficacy of a house dust mite (HDM) polymerized allergen extract mixture for allergic rhinoconjunctivitis (AR) according to both the EMA and European Academy of Allergy and Clinical Immunology (EAACI) guidelines for the clinical development of products for the treatment of AR. Methods We will perform a double-blind, placebo-controlled, randomized parallel group phase III clinical trial to assess the clinical efficacy and safety of a polymerized Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract mixture (Beltavac®) to treat perennial AR in children and adults. Patients with moderate or severe rhinitis symptoms, either associated or not with asthma and confirmed HDM sensitization and without relevant concomitant conditions that may interfere with the planned evaluations test are eligible. Patients will be randomized in a 1:1 ratio to either the active AIT or placebo. The experimental group will receive 12 monthly AIT doses via subcutaneous route with a potency of 2 RC/ml per allergen. The expected sample size is 250 patients from 16 sites in Spain. The main efficacy outcome is the Combined Symptom and Medication Score (CSMS) for rhinitis. It will be patients’ self-assessed and collected through a phone App developed ad hoc for the study to improve the patient adherence and the quality of data. Main secondary outcomes include expanded CSMS for rhinoconjunctivitis symptoms, control of rhinitis, specific IgE and IgG4 values, quality of life, and the number of adverse reactions. Health-related direct and indirect costs will be also evaluated. Finally, several exploratory parameters will be used to assess the severity of asthma. Discussion This phase III clinical trial will be of interest to contribute to the scientific evidence about the efficacy and safety of AIT with allergoids. Our working hypothesis is that the investigational product in patients with AR associated or not with asthma is superior to placebo in providing a clinically significant improvement according to the standards defined by the EAACI. This trial will also supply valuable information about patients reported outcomes using health technology for rhinoconjunctivitis and asthma assessment. Trial registration EudraCT 2018–003427-11. Date on which this record was first entered in the: 2021–06-14. This study is funded by Probelte Pharma S.L.U. with the support of the Spanish Department of Science and Innovation (CDTI Programme). http://hdl.handle.net/11351/13870 Avaluació de resultats (Assistència sanitària) Rinitis - Tractament Febre del fenc - Tractament Immunosupressió Antígens Àcars ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome CHEMICALS AND DRUGS::Biological Factors::Antigens::Antigens, Dermatophagoides ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Investigative Techniques::Immunologic Techniques::Immunosuppression::Desensitization, Immunologic DISEASES::Respiratory Tract Diseases::Respiratory Tract Diseases::Respiratory Hypersensitivity::Rhinitis, Allergic Other subheadings::Other subheadings::/therapy TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento COMPUESTOS QUÍMICOS Y DROGAS::factores biológicos::antígenos::antígenos de Dermatophagoides TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::técnicas de investigación::técnicas inmunológicas::inmunosupresión::desensibilización inmunológica ENFERMEDADES::enfermedades respiratorias::enfermedades respiratorias::hipersensibilidad respiratoria::rinitis alérgica Otros calificadores::Otros calificadores::/terapia Efficacy and safety of a house dust mites allergoid in patients with allergic rhinitis-PROACAROS study: protocol for a randomized controlled trial