NCT03662711

Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease

Comparison of 1-year Treatment With Inhaled Long Acting Bronchodilators (LABD) Plus Inhaled Glucocorticosteroids (ICS) Versus LABD Without ICS on Re-hospitalizations and/or Death in Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD) Recently Hospitalized Because of an Acute Exacerbation of COPD (ICS-Life Study).

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 843 (actual)
• Sponsor: Università degli Studi di Ferrara · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Bronchodilator Agents	Fluticasone furoate/vilanterol
DRUG	Bronchodilator Agents	Tiotropium
DRUG	Bronchodilator Agents	Indacaterol
DRUG	Bronchodilator Agents	Umeclidinium/vilanterol
DRUG	Bronchodilator Agents	Fluticasone propionate/salmeterol
DRUG	Bronchodilator Agents	Beclometasone dipropionate/formoterol
DRUG	Bronchodilator Agents	Budesonide formoterol
DRUG	Bronchodilator Agents	Glycopyrronium
DRUG	Bronchodilator Agents	Aclidinium
DRUG	Bronchodilator Agents	Umeclidinium
DRUG	Bronchodilator Agents	Formoterol
DRUG	Bronchodilator Agents	Indacaterol glycopyrronium
DRUG	Bronchodilator Agents	Salmeterol
DRUG	Bronchodilator Agents	Tiotropium olodaterol
DRUG	Bronchodilator Agents	Aclidinium/formoterol
DRUG	Bronchodilator Agents	Olodaterol
DRUG	Bronchodilator Agents	Formoterol/glycopyrronium bromide/beclometasone dipropionate
DRUG	Bronchodilator Agents	Fluticasone furoate/umeclidinium bromide/vilanterol

Timeline

• Start date: 2018-11-11
• Primary completion: 2022-10-26
• Completion: 2022-10-26
• First posted: 2018-09-07
• Last updated: 2022-12-28

Locations

39 sites across 1 country: Italy