Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial
Antonio Nieto, Ángel Mazón, María Nieto, Rafael Burgos-Calderón, Susana Calaforra, Blanca Selva, Sonia Uixera, Maria José Palao, Paola Brandi, Laura Conejero, Paula Saz-Leal, Cristina Fernández, David Sancho, José Luis Subiza, Miguel Casanovas
Abstract
Abstract 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 (NCT 01734811).