Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study.

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 ß2-agonistsICS:inhaled corticosteroidsCRF:Case Report Form.

Electronic cigarette use among Italian smokers: patterns, settings, and adverse events.

OBJECTIVE: Information is scanty on the patterns and settings of electronic cigarette use and on its possible adverse events. To fill the knowledge gap on these issues, we conducted a survey among ever-smokers attending smoking cessation services (SCS) in Italy. METHODS: In 2016-2018, we enrolled 395 ever-smokers aged ⩾18 years who were current or former electronic cigarette users in 12 SCS from northern, central, and southern Italy. RESULTS: In all, 12.4% of ever smokers were regular, 9.4% occasional, and 78.2% past users of electronic cigarettes. Of all users, 93.8% consumed electronic cigarettes with nicotine, 95.9% used refillable devices, and 76.6% purchased electronic cigarette devices or liquids in vape shops. The mean duration of use was 3.7 months and the mean number of puffs per day was 86. Among users, 71.5% used electronic cigarettes in at least 1 smoke-free indoor environment, 53.7% in workplaces, 49.5% in restaurants and bars, 33.5% in train/metro stations or airports, and 18.4% in public transports. The use of electronic cigarettes in smoke-free environments significantly decreased with age and increased with duration of use and nicotine dependence. In our sample, 47.1% reported at least 1 adverse event attributable to electronic cigarette use: 19.5% dry cough, 12.0% dry mouth, 7.6% throat or mouth irritation, and 6.8% sore throat. CONCLUSION: In Italy, most conventional cigarette smokers use electronic cigarettes where smoking conventional cigarettes is prohibited. About half of users reported 1 or more symptoms attributable to electronic cigarettes, despite the relatively short duration of use.