Bacterial Mucosal Immunotherapy with MV130 Prevents Recurrent Wheezing in Children: A Randomized, Double-Blind, Placebo-controlled Clinical Trial.

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).

Validation of the food allergy independent measure and the EuroPrevall food allergy quality of life questionnaire for children 8-12 years translated into Spanish.

BACKGROUND: Different questionnaires have been developed to measure quality of life (QoL) in patients with food allergy. Our aim was to validate a Spanish translation of the Food Allergy Independent Measure (FAIM) and the EuroPrevall Food Allergy Quality of Life Questionnaire-Child Form (FAQLQ-CF) for children aged 8-12 years. METHODS: Sixty children with a diagnosis of IgE-mediated allergy to food completed the questionnaires. The internal consistency was evaluated with Cronbach's alpha. The correlation of FAQLQ-CF with FAIM was assessed to test construct validity. We compared both values with the diagnosis of anaphylaxis to evaluate discriminant validity. RESULTS: Cronbach's alpha was in the range of 0.654-0.863 for the four domains of FAQLQ-CF and 0.779 for FAIM. There were no criteria to remove questions from the questionnaires. Significant correlations could be found between FAQLQ-CF and the number of offending foods and the impact on social life (all r > 0.33, P < 0.01), and between FAIM and anaphylaxis. CONCLUSIONS: The Spanish translation of FAQLQ-CF showed acceptable internal consistency, good construct validity, and capacity to discriminate patients depending on the number of foods to avoid and the impact on social life. FAIM showed good discriminant capacity for anaphylaxis.

Food allergy in adolescents: validation of the food allergy independent measure and the EuroPrevall food allergy quality of life questionnaire into Spanish

Background: Different questionnaires have been developed globally to assess and compare the impact of food allergy on the quality of life. The aim of this study was to validate a Spanish translation of the Food Allergy Independent Measure (FAIM) and the EuroPrevall Food Allergy–Quality of Life Questionnaire–Teenage Form (FAQLQ-TF) for adolescents aged 13–17 years. Methods: Sixty adolescents diagnosed with immunoglobulin E-mediated allergy to food completed the questionnaires. Cronbach’s alpha was used to assess internal consistency; correlation between FAQLQ-TF and FAIM was used to test construct validity. The discriminant validity was evaluated by comparison with the number of offending foods, the perceived impact on social life, the diagnosis of anaphylaxis, and the previous prescription of adrenaline auto--injectors (AAI). Results: No question fulfilled criteria to be removed from the questionnaire. For FAIM, Cronbach’s alpha = 0.763, and for the four domains of FAQLQ-TF, Cronbach’s alpha = 0.797–0.847. A significant correlation existed between FAQLQ-TF and FAIM, and of both of them with anaphylaxis and the prescription of AAI (P ˂ 0.05 for all comparisons). Conclusions: This Spanish translation of FAIM and FAQLQ-TF for adolescents had good internal consistency and construct validity as well as ability to discriminate patients according to the number of foods to avoid, impact on social life, diagnosis of anaphylaxis, and AAI prescription (AU)

Validation of the food allergy independent measure and the EuroPrevall food allergy quality of life questionnaire for children 8–12 years translated into Spanish

Background Different questionnaires have been developed to measure quality of life (QoL) in patients with food allergy. Our aim was to validate a Spanish translation of the Food Allergy Independent Measure (FAIM) and the EuroPrevall Food Allergy Quality of Life Questionnaire—Child Form (FAQLQ-CF) for children aged 8–12 years.Methods Sixty children with a diagnosis of IgE-mediated allergy to food completed the questionnaires. The internal consistency was evaluated with Cronbach’s alpha. The correlation of FAQLQ-CF with FAIM was assessed to test construct validity. We compared both values with the diagnosis of anaphylaxis to evaluate discriminant validity.Results Cronbach’s alpha was in the range of 0.654–0.863 for the four domains of FAQLQ-CF and 0.779 for FAIM. There were no criteria to remove questions from the questionnaires. Significant correlations could be found between FAQLQ-CF and the number of offending foods and the impact on social life (all r > 0.33, P < 0.01), and between FAIM and anaphylaxis.Conclusions The Spanish translation of FAQLQ-CF showed acceptable internal consistency, good construct validity, and capacity to discriminate patients depending on the number of foods to avoid and the impact on social life. FAIM showed good discriminant capacity for anaphylaxis (AU).