2026-04-29T02:37:38Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/151592024-11-29T08:35:45Zcom_20.500.12105_19604com_20.500.12105_2051com_20.500.12105_15322col_20.500.12105_19605col_20.500.12105_16969col_20.500.12105_16975

00925njm 22002777a 4500 dc Nieto, Antonio author Mazón, Angel author Nieto, María author Calderón, Rafael author Calaforra, Susana author Selva, Blanca author Uixera, Sonia author Palao, Maria José author Brandi, Paola author Conejero, Laura author Saz-Leal, Paula author Fernández-Pérez, Cristina author Sancho, David author Subiza, José Luis author Casanovas, Miguel author 2021 Rationale: Recurrent wheezing in children represents a severe public health concern. Wheezing attacks (WA), mainly associated with viral infections, lack effective preventive therapies. Objectives: To evaluate the efficacy and safety of mucosal sublingual immunotherapy based on whole inactivated bacteria (MV130) in preventing WA in children. Methods: A Phase 3 randomized, double-blind, placebo-controlled, parallel-group trial including a cohort of 120 children <3 years old with ⩾3 WA during the previous year was conducted. Children with a positive skin test to common aeroallergens in the area where the clinical trial was performed were excluded from the trial. Subjects received MV130 or placebo daily for 6 months. The primary endpoint was the number of WA within 1 year after the first dose comparing MV130 and placebo. Measurements and Main Results: There was a significant lower number of WA in MV130 versus the placebo group, 3.0 (interquartile range [IQR], 2.0-4.0) versus 5.0 (IQR, 3.0-7.0) (P < 0.001). As secondary outcomes, a decrease in the duration of WA and a reduction in symptoms and medication scores in the MV130 versus placebo group were found. No adverse events were reported related to the active treatment. Conclusions: Mucosal bacterial immunotherapy with MV130 shows safety and clinical efficacy against recurrent WA in children.Clinical trial registered with www.clinicaltrials.gov (NCT01734811). Am J Respir Crit Care Med . 2021 Aug 15;204(4):462-472 http://hdl.handle.net/20.500.12105/15159 33705665 10.1164/rccm.202003-0520OC 1535-4970 American journal of respiratory and critical care medicine Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial.