Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children A Randomized, Double-Blind, Placebo-controlled Clinical Trial
Por:
Nieto, A, Mazon, A, Nieto, M, Calderon, R, Calaforra, S, Selva, B, Uixera, S, Palao, M, Brandi, P, Conejero, L, Saz-Leal, P, Fernandez-Perez, C, Sancho, D, Subiza, J and Casanovas, M
Publicada:
15 ago 2021
Resumen:
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.
Filiaciones:
Nieto, A:
Hosp Univ La Fe, Inst Invest Sanitarias, Unidad Neumol & Alergia Pediat, Avinguda Fernando Abril Martorell 106, Valencia 46026, Spain
Mazon, A:
Hosp Univ La Fe, Inst Invest Sanitarias, Unidad Neumol & Alergia Pediat, Avinguda Fernando Abril Martorell 106, Valencia 46026, Spain
:
Hosp Univ La Fe, Inst Invest Sanitarias, Unidad Neumol & Alergia Pediat, Avinguda Fernando Abril Martorell 106, Valencia 46026, Spain
Calderon, R:
Manises Hosp, Dept Pediat, Valencia, Spain
Calaforra, S:
Hosp Univ La Fe, Inst Invest Sanitarias, Unidad Neumol & Alergia Pediat, Avinguda Fernando Abril Martorell 106, Valencia 46026, Spain
Selva, B:
Hosp Univ La Fe, Inst Invest Sanitarias, Unidad Neumol & Alergia Pediat, Avinguda Fernando Abril Martorell 106, Valencia 46026, Spain
Uixera, S:
Hosp Univ La Fe, Inst Invest Sanitarias, Unidad Neumol & Alergia Pediat, Avinguda Fernando Abril Martorell 106, Valencia 46026, Spain
Palao, M:
Manises Hosp, Dept Pediat, Valencia, Spain
Brandi, P:
Ctr Nacl Invest Cardiovasc, Madrid, Spain
Conejero, L:
Inmunotek SL, Alcala De Henares, Spain
Saz-Leal, P:
Inmunotek SL, Alcala De Henares, Spain
Fernandez-Perez, C:
Univ Complutense, Hosp Clin San Carlos, Inst Invest Sanitaria, Madrid, Spain
Sancho, D:
Ctr Nacl Invest Cardiovasc, Madrid, Spain
Subiza, J:
Inmunotek SL, Alcala De Henares, Spain
Casanovas, M:
Inmunotek SL, Alcala De Henares, Spain
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