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).
The Renal Health Model and its program is being built into public health care policies of countries in Latin America and the Caribbean and adapted to the needs of each country with an increasing acceptance on the part of health care professionals. It should not be implemented in isolation but within the framework of non transmissible diseases.
The implementation of the Renal Health Program in health ministries of Latin American and Caribbean countries would allow for a substantial improvement in renal health prevention and management, as a result of better distribution of financial and human resources.
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