This will be a phase IV, open label, multicenter, randomized pragmatic study in frail elderly patients with COPD. Participants will be treated with either inhaled LABD alone or LABD combined with inhaled glucocorticosteroids. The main aim of the study is to assess whether, in elderly patients with COPD and one or more cardiac comorbidities (heart failure, and/or ischemic heart disease, and/or atrial fibrillation) recently hospitalized because of an acute exacerbation of COPD, 12 months treatment with LABD(s)+ICS can increase the time to first re-hospitalization (all cause) and/or death for any cause when compared with LABD(s) alone. Patients will be followed-up for 3 months after completion of the 12 month treatment period.
Chronic obstructive pulmonary disease occurs mainly in the elderly and has important comorbidities, particularly cardiovascular, which increase its severity. Chronic obstructive pulmonary disease affects 5% of people globally, increasing to 10% in the elderly. According to data from the World Health Organisation (WHO), there were 384 million cases of COPD in 2010, with a global prevalence of 12% (www.who.int). Deaths due to COPD are 3 million/year globally (GOLD 2018) and \>20,000/year in Italy. The investigator speculated that multimorbid elderly COPD patients recently hospitalized due to an acute exacerbation of COPD (AECOPD) and who have concomitant cardiovascular disease may have fewer re-hospitalizations and increased survival in the following year if treated with LABD+ICS rather than with LABD alone. The aim of this study is to examine the efficacy and safety of currently recommended and prescribed inhalation therapies to elderly, frail and multimorbid COPD patients with a recent hospitalization due to an AECOPD. The study involves a group of patients who have never before been selected for a clinical trial and who represent the 5th most common cause of hospitalization and the 3rd most common cause of death in Italy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
843
Fluticasone furoate/vilanterol
Tiotropium
Indacaterol
Umeclidinium/vilanterol
Fluticasone propionate/salmeterol
Beclometasone dipropionate/formoterol
Budesonide formoterol
Glycopyrronium
Aclidinium
Umeclidinium
Formoterol
Indacaterol glycopyrronium
Salmeterol
Tiotropium olodaterol
Aclidinium/formoterol
Olodaterol
Formoterol/glycopyrronium bromide/beclometasone dipropionate
Fluticasone furoate/umeclidinium bromide/vilanterol
Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa
Cassano delle Murge, Apulia, Italy
Policlinico di Bari, U.O.C. Malattie dell'Apparato Respiratorio Universitaria
Bari, BA, Italy
Istituti Clinici Scientifici Maugeri S.p.A - SB, Pneumologia Riabilitativa
Telese Terme, Benevento, Italy
Dipartimento Di Scienze Mediche e Chirurgiche- Università Magna Grecia
Catanzaro, Calabria, Italy
Ospedale San Giovanni di Dio, UOC Medicina Interna
Crotone, Calabria, Italy
Composite event of the first time to first re-hospitalization and/or death (all cause)
Time frame: 12 months
Number of moderate/severe COPD exacerbations in the two patient groups
Time frame: 12 months
Number of re-hospitalizations and deaths (all cause) in the two patient groups
Time frame: 12 months
Quality of life (QoL) variation measured as change in COPD Assessment Test (CAT) between the two patient groups
Time frame: 12 months
QoL variation measured using modified Medical Research Council (mMRC) dyspnoea scale between the two patient groups
Time frame: 12 months
Number of pneumonia events
Time frame: 12 months
Number of acute cardiac events
Time frame: 12 months
Number of cardiovascular events
Time frame: 12 months
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Ospedale "Jazzolino" ASP, UOC Medicina Interna
Vibo Valentia, Calabria, Italy
Ospedale civile di Battipaglia, Medicina, Servizio di Allergologia e Immunologia Clinica
Battipaglia, Campania, Italy
Azienda Ospedaliera dei Colli - Ospedale Monaldi
Napoli, Campania, Italy
Università degli studi di Modena e Reggio Emilia, Clinica Malattie dell'apparato Respiratorio
Modena, Emilia-Romagna, Italy
Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica
Parma, Emilia-Romagna, Italy
...and 29 more locations