Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease
NCT03662711 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 843
Last updated 2022-12-28
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.
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- 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
Sponsors & Collaborators
-
Università degli Studi di Ferrara
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-11-11
- Primary Completion
- 2022-10-26
- Completion
- 2022-10-26
Countries
- Italy
Study Locations
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