Mild/Moderate Asthma Network in Italy (MANI): a long-term observational study
Fulvio Braido, Francesco Blasi, Giorgio Walter Canonica, Pierluigi Paggiaro, Bianca Beghè, Matteo Bonini, Giovanna Elisiana Carpagnano, Stefano Del Giacco, Federico Lavorini, Manlio Milanese, Vincenzo Patella, Pierachille Santus, Marco Contoli, MANI Network, Chiara Allegrini, Ilaria Baiardini, Laura Bonzano, Maria Filomena Caiaffa, Paolo Castelnuovo, Angelo Guido Corsico, Lorenzo Cosmi, Maria Teresa Costantino, Marcello Cottini, Nunzio Crimi, Maria Angiola Crivellaro, Simona D'Alò, Ilenia Folletti, Dario Fornari, Maria Pia Foschino-Barbaro, Laura Franceschini, Domenico Gargano, Kim Lokar Oliani, Mauro Maniscalco, Laura Melissari, Marcello Montagni, Paolo Montuschi, Nicola Murgia, Alessandro Pannofino, Alberto Papi, Roberta Parente, Girolamo Pelaia, Laura Pini, Francesca Puggioni, Nolita Pulerà, Onofrio Resta, Luisa Ricciardi, Erminia Ridolo, Eleonora Savi, Francesca Savoia, Guglielmo Scala, Gianenrico Senna, Salvatore Tripodi, Alessandro Vatrella, Maria Teresa Ventura, Vittorio Maria Viviano, Mona-Rita Yacoub, Fulvio Braido, Francesco Blasi, Giorgio Walter Canonica, Pierluigi Paggiaro, Bianca Beghè, Matteo Bonini, Giovanna Elisiana Carpagnano, Stefano Del Giacco, Federico Lavorini, Manlio Milanese, Vincenzo Patella, Pierachille Santus, Marco Contoli, MANI Network, Chiara Allegrini, Ilaria Baiardini, Laura Bonzano, Maria Filomena Caiaffa, Paolo Castelnuovo, Angelo Guido Corsico, Lorenzo Cosmi, Maria Teresa Costantino, Marcello Cottini, Nunzio Crimi, Maria Angiola Crivellaro, Simona D'Alò, Ilenia Folletti, Dario Fornari, Maria Pia Foschino-Barbaro, Laura Franceschini, Domenico Gargano, Kim Lokar Oliani, Mauro Maniscalco, Laura Melissari, Marcello Montagni, Paolo Montuschi, Nicola Murgia, Alessandro Pannofino, Alberto Papi, Roberta Parente, Girolamo Pelaia, Laura Pini, Francesca Puggioni, Nolita Pulerà, Onofrio Resta, Luisa Ricciardi, Erminia Ridolo, Eleonora Savi, Francesca Savoia, Guglielmo Scala, Gianenrico Senna, Salvatore Tripodi, Alessandro Vatrella, Maria Teresa Ventura, Vittorio Maria Viviano, Mona-Rita Yacoub
Abstract
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.
Keywords: Cross-sectional; patient-reported outcomes; prospective cohort study; registry.
Source: PubMed