Background: Recurrent persistent cough and wheezing often begin in early childhood; however, not all episodes of them are caused by asthma and/or an allergic reaction, they are exacerbated with several respiratory infections. Previous research suggests that the best treatment for toddlers and preschool-age children with persistent cough and/or wheeze is a difficult clinical challenge. Methods: In this single-center prospective clinical trial, HIROSIMA study, we observed the clinical effect of oral leukotriene receptor antagonists (LTRAs: montelukast, pranlukast) with carbocystein and lysozyme chloride or ambroxol for over a year and assessed the relationship between infantile wheeze, chronic cough and rhinosinusitis. The patients were allocated to the intervention with their consent. Results: Eighty patients, who were admitted to hospital for persistent cough and dyspnea episodes, completed the study for a year and showed significantly fewer asthma exacerbation episodes (clinical asthma scores/week; 16.1 ± 3.1 vs 7.9 ± 2.7) during the first eight weeks (p < 0.01), comparing to the use of LTRA alone (n = 40).; and the improvement of conditions persisted for over the twelve-month period. None of the subjects was admitted to the hospital for asthma exacerbation, and had any corticosteroid treatment during the study. Conclusion: Our strategy for chronic cough including the management of allergic rhinitis and sinusitis significantly evaded persistent cough and wheeze of children age from 1 to 5 years, and reduced the frequency of recurrent otitis media. Note: HIROSIMA study provides promising data for the control of persistent cough and wheeze of children age from 1 to 5 years without the use of corticosteroids for over a year with a good adherence to the treatment.
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