• Antonio Nieto, Angel Mazón, María Nieto, Rafael Calderón, Susana Calaforra, Blanca Selva, Sonia Uixera, Maria José Palao, Paola Brandi, Laura Conejero, Paula Saz-Leal, Cristina Fernández-Pérez, David Sancho, José Luis Subiza, and Miguel Casanovas.
• Unidad de Neumología y Alergia Pediátrica, Instituto de Investigaciones Sanitarias, Hospital Universitario La Fe, Valencia, Spain.
• Am. J. Respir. Crit. Care Med. 2021 Aug 15; 204 (4): 462472462-472.

AbstractRationale: 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).

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