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Many asthmatic patients remain uncontrolled despite treatment with inhaled corticosteroids (ICS) and long-acting β2 adrenergic bronchodilators (LABA). Triple therapy with a single inhaler (SITT) offers a new, safe, and effective treatment option for patients with uncontrolled asthma with mid to high-dose ICS/LABA. [ABSTRACT FROM AUTHOR]

Objective: The prevalence of asthma in Italy is estimated to be around 4%; it affects approximately 2,000,000 citizens, and up to 80-90% of patients have mild-to-moderate asthma. Despite the clinical relevance of mild-to-moderate asthma, longitudinal observational data are very limited, including data on disease progression (worsening vs. improvement), the response to treatment, and prognosis. Studies are needed to develop long-term, observational, real-life research in large cohorts. The primary outcomes of this study will be based on prospective observation and the epidemiological evolution of mild and moderate asthma. Secondary outcomes will include patient-reported outcomes, treatments over time, disease-related functional and inflammatory patterns, and environmental and life-style influences., Methods: This study, called the Mild/Moderate Asthma Network of Italy (MANI), is a research initiative launched by the Italian Respiratory Society and the Italian Society of Allergology, Asthma and Clinical Immunology. MANI is a cluster-based, real world, cross-sectional, prospective, observational cohort study that includes 20,000 patients with mild-to-moderate asthma. (ClinicalTrials.gov Identifier: NCT04796844)., Results and Conclusion: Despite advances in asthma care, several research gaps remain to be addressed through clinical research. This study will add important new knowledge about long-term disease history, the transferability of clinical research results to daily practice, the efficacy of currently recommended strategies, and their impact on the burden and evolution of the disease., Abbreviations: MANI:Mild/Moderate Asthma Network of ItalySANI:Severe Asthma Network ItalyGINA:Global Initiative for AsthmaSABA:short acting β2-agonistsICS:inhaled corticosteroidsCRF:Case Report Form.

An association between date of birth and development of allergy has been proposed by prior research. Yet, the presence of a dose-response relationship or any potential effect modification for this association has not been widely studied. The aims of our study were to investigate whether an association between birth during pollen season and symptomatic sensitization to pollens exists, whether this association is stronger for patients with high rather than low allergic reactivity to pollens, and whether this association is modified by the age of the patients. Among 3318 asthmatic and/or rhinitic outpatients, we selected 805 patients sensitized exclusively to pollens (78 with low reactivity [LR] and 727 with high reactivity [HR]) and 629 patients with negative skin-prick tests (SPT) (control group). The association between being born during pollen season (February-July) and each of the pollen reactivity levels was assessed by estimating the odds ratios (OR). HR pollinosis patients were more likely than SPT negative patients of being born in February-July (OR 1.38, 95% Confidence Intervals (CI) 1.11-1.71). The likelihood of having been born in pollen season significantly increased across the levels of reactivity to pollens (HR > LR > SPT negative). These findings were valid only among patients with an early onset of symptoms. Although the OR for being born in pollen season was 1.91 (95% CI 1.32-2.77) for HR pollinosis patients with onset of symptoms < or = 15 years, it was 1.13 (95% CI 0.87-1.48) for those with later onset of symptoms (test of homogeneity: p = 0.026). Our results suggest that the exposure to allergenic pollens in the first months of life increases the risk of developing clinically relevant sensitization to them, particularly in the first 15 years of life.