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

NCT ID: NCT03662711

Last Updated: 2022-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

843 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-11

Study Completion Date

2022-10-26

Brief Summary

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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

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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

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Pulmonary Disease, Chronic Obstructive

Keywords

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adult drug therapy combination bronchodilator agents male female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Long-acting beta-agonist (LABA) or LABA/LAMA

long-acting bronchodilator agents (LABD, LAMA or LABA/LAMA) but no inhaled steroids plus usual care for comorbidities

Group Type ACTIVE_COMPARATOR

Bronchodilator Agents

Intervention Type DRUG

Tiotropium

Bronchodilator Agents

Intervention Type DRUG

Indacaterol

Bronchodilator Agents

Intervention Type DRUG

Umeclidinium/vilanterol

Bronchodilator Agents

Intervention Type DRUG

Glycopyrronium

Bronchodilator Agents

Intervention Type DRUG

Aclidinium

Bronchodilator Agents

Intervention Type DRUG

Umeclidinium

Bronchodilator Agents

Intervention Type DRUG

Formoterol

Bronchodilator Agents

Intervention Type DRUG

Indacaterol glycopyrronium

Bronchodilator Agents

Intervention Type DRUG

Salmeterol

Bronchodilator Agents

Intervention Type DRUG

Tiotropium olodaterol

Bronchodilator Agents

Intervention Type DRUG

Aclidinium/formoterol

Bronchodilator Agents

Intervention Type DRUG

Olodaterol

Long-acting muscarinic antagonist (LAMA) and/or LABA plus ICS

Bronchodilator agents LAMA and/or LABA with inhaled steroids plus usual care for comorbidities

Group Type EXPERIMENTAL

Bronchodilator Agents

Intervention Type DRUG

Fluticasone furoate/vilanterol

Bronchodilator Agents

Intervention Type DRUG

Fluticasone propionate/salmeterol

Bronchodilator Agents

Intervention Type DRUG

Beclometasone dipropionate/formoterol

Bronchodilator Agents

Intervention Type DRUG

Budesonide formoterol

Bronchodilator Agents

Intervention Type DRUG

Formoterol/glycopyrronium bromide/beclometasone dipropionate

Bronchodilator Agents

Intervention Type DRUG

Fluticasone furoate/umeclidinium bromide/vilanterol

Interventions

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Bronchodilator Agents

Fluticasone furoate/vilanterol

Intervention Type DRUG

Bronchodilator Agents

Tiotropium

Intervention Type DRUG

Bronchodilator Agents

Indacaterol

Intervention Type DRUG

Bronchodilator Agents

Umeclidinium/vilanterol

Intervention Type DRUG

Bronchodilator Agents

Fluticasone propionate/salmeterol

Intervention Type DRUG

Bronchodilator Agents

Beclometasone dipropionate/formoterol

Intervention Type DRUG

Bronchodilator Agents

Budesonide formoterol

Intervention Type DRUG

Bronchodilator Agents

Glycopyrronium

Intervention Type DRUG

Bronchodilator Agents

Aclidinium

Intervention Type DRUG

Bronchodilator Agents

Umeclidinium

Intervention Type DRUG

Bronchodilator Agents

Formoterol

Intervention Type DRUG

Bronchodilator Agents

Indacaterol glycopyrronium

Intervention Type DRUG

Bronchodilator Agents

Salmeterol

Intervention Type DRUG

Bronchodilator Agents

Tiotropium olodaterol

Intervention Type DRUG

Bronchodilator Agents

Aclidinium/formoterol

Intervention Type DRUG

Bronchodilator Agents

Olodaterol

Intervention Type DRUG

Bronchodilator Agents

Formoterol/glycopyrronium bromide/beclometasone dipropionate

Intervention Type DRUG

Bronchodilator Agents

Fluticasone furoate/umeclidinium bromide/vilanterol

Intervention Type DRUG

Other Intervention Names

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Revinty Ellipta Spiriva Respimat Onbreez Brezhaler 150 Laventair Aliflus Diskus 50/500 Alabaster Fobuler Tovanor Breezhaler Bretaris Genuair Incruse Levovent Ultibro Breezhaler Serevent Spiolto Respimat Duaklir Genuair Striverdi Respimat Trimbow Elebrato Ellipta

Eligibility Criteria

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Inclusion Criteria

1. Participant must be older than 60 years of age, at the time of signing the informed consent.
2. Recently (within 6 months) discharged from hospital with a diagnosis of acute exacerbation of COPD (usually coded as Diagnosis Related Group (DRG) 087 or 088).
3. Participants with a clinical diagnosis of COPD (i.e. previous diagnosis of COPD and/or treatment with short acting bronchodilators (SABD), LABD or LABD+ICS
4. Spirometry confirmed diagnosis of COPD, post-bronchodilator (30 minutes after 400 μg salbutamol) FEV1/FVC ratio \<0.7. The diagnostic spirometry test can have been performed up to three years prior to randomization, or if never performed before, should be performed not earlier than 4 weeks since last exacerbation
5. Smokers or ex-smokers with a smoking history of \>10 pack years (a pack year is defined as 20 cigarettes smoked every day for a year)
6. Clinical diagnosis documented in the patient's medical records of one or more major chronic cardiac disease (heart failure, ischemic heart disease or atrial fibrillation).
7. Currently receiving at least one of the specified treatments (either alone or in combination, see Appendix 10.5) for heart failure, ischemic heart disease or atrial fibrillation.
8. Participant must be willing and able to perform pulmonary function tests
9. Male or female. Contraception is not considered necessary in this cohort of elderly (\> 65 years) patients receiving treatment with commercially available licensed products.
10. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria

1. Patients with a primary discharge diagnosis of DRG 087 or DRG 088 but clearly judged by the clinical investigator to be due to other causes, i.e. patients presenting to the hospital with symptoms of AECOPD but due mainly to other conditions (pulmonary embolism, pneumonia, pneumothorax, anemia, acute kidney failure, decompensated heart failure, acute ischemic heart disease, new onset atrial fibrillation, stroke, etc.)
2. Patients who required invasive mechanical ventilation during hospitalization
3. Patients with Asthma as primary and principal diagnosis
4. Patients with severe cardiovascular (CV) disease who in the opinion of the investigator are unlikely to survive the 15 month study period
5. Patients considered unable to comply with the study procedures and follow-up in the opinion of the investigator (eg, evidence of alcohol or drug abuse, psychiatric disorder, physical disability, social or geographical obstacles)
6. Patients in whom spirometry is contraindicated (eg, hemoptysis, detached retina, active tuberculosis, last trimester of pregnancy)
7. Patients with other mechanical or overt causes of respiratory symptoms, particularly dyspnea (such as pneumothorax, chest wall trauma, lung fibrosis, lung cancer, anemia, severe obesity (BMI \>40) or cachexia (BMI \<18))
8. Patients with any major disease which in the opinion of the investigator would prevent study participation, such as dementia, end-stage disease, cachexia, chronically bedridden patient and life expectancy \<15 months.
9. Participation in any other interventional study within the last 3 months or concurrent participation in an observational clinical study.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Ferrara

OTHER

Sponsor Role lead

Responsible Party

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Alberto Papi, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa

Cassano delle Murge, Apulia, Italy

Site Status

Policlinico di Bari, U.O.C. Malattie dell'Apparato Respiratorio Universitaria

Bari, BA, Italy

Site Status

Istituti Clinici Scientifici Maugeri S.p.A - SB, Pneumologia Riabilitativa

Telese Terme, Benevento, Italy

Site Status

Dipartimento Di Scienze Mediche e Chirurgiche- Università Magna Grecia

Catanzaro, Calabria, Italy

Site Status

Ospedale San Giovanni di Dio, UOC Medicina Interna

Crotone, Calabria, Italy

Site Status

Ospedale "Jazzolino" ASP, UOC Medicina Interna

Vibo Valentia, Calabria, Italy

Site Status

Ospedale civile di Battipaglia, Medicina, Servizio di Allergologia e Immunologia Clinica

Battipaglia, Campania, Italy

Site Status

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Napoli, Campania, Italy

Site Status

Università degli studi di Modena e Reggio Emilia, Clinica Malattie dell'apparato Respiratorio

Modena, Emilia-Romagna, Italy

Site Status

Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica

Parma, Emilia-Romagna, Italy

Site Status

AUSL - IRCCS di Reggio Emilia, Pneumologia

Reggio Emilia, Emilia-Romagna, Italy

Site Status

UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO

Ferrara, FE, Italy

Site Status

Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio

Foggia, FG, Italy

Site Status

Ospedale S. Maria degli Angeli - AAS5 Friuli Occidentale, Pneumologia

Pordenone, Friuli Venezia Giulia, Italy

Site Status

Policlinico Universitario Campus Biomedico di Roma, Medicina Interna e Geriatria

Rome, Lazio, Italy

Site Status

Università di Roma "Tor Vergata", Dipartimento di Medicina dei Sistemi, Malattie dell'apparato respiratorio

Rome, Lazio, Italy

Site Status

ASL2 Savonese, Ospedale S. Corona, Pneumologia

Pietra Ligure, Liguria, Italy

Site Status

Ospedale San Paolo, Medicina 2 e cure Intermedie

Savona, Liguria, Italy

Site Status

Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Site Status

Ospedale Figlie di San Camillo, Medicina Interna

Cremona, Lombardy, Italy

Site Status

Ospedale "Carlo Poma", Struttura Complessa Pneumologia e UTIR

Mantova, Lombardy, Italy

Site Status

Ospedale "L. Sacco" - Polo Universitario ASST Fatebenefratelli Sacco, Pneumologia

Milan, Lombardy, Italy

Site Status

Fondazione IRCCS Policlinico San Matteo, Pneumologia

Pavia, Lombardy, Italy

Site Status

Istituti Clinici Scientifici Fondazione Maugeri, Pneumologia Riabilitativa

Pavia, Lombardy, Italy

Site Status

Istituti Clinici Scientifici maugeri, Pneumologia Riabilitativa

Tradate, Lombardy, Italy

Site Status

Università degli Studi di Palermo, Ospedale "V. Cervello"

Palermo, Pa, Italy

Site Status

Ospedale Maggiore, Medicina interna

Chieri, Piedmont, Italy

Site Status

Ospedale di Ceva, Medicina interna

San Bernardino, Piedmont, Italy

Site Status

Ospedale Civile SS. Annunziata, Medicina interna

Savigliano, Piedmont, Italy

Site Status

Policlinico Ospedaliero di Varese - Ospedale di Circolo e Fondazione Macchi, Medicina interna

Varese, Piedmont, Italy

Site Status

Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa

Veruno, Piedmont, Italy

Site Status

Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele", Pneumologia

Catania, Sicily, Italy

Site Status

Ospedali Riuniti di Ancona, Pneumologia

Torrette, The Marches, Italy

Site Status

Ospedale di Cattinara, unità operativa di pneumologia

Trieste, TS, Italy

Site Status

Azienda Ospedaliero-universitaria Careggi, Medicina per la alta complessità Assistenziale 1

Florence, Tuscany, Italy

Site Status

Azienda Ospedaliero-universitaria Careggi, Medicina per la alta complessità Assistenziale 2

Florence, Tuscany, Italy

Site Status

Università degli studi di Siena, UOC Malattie respiratorie

Siena, Tuscany, Italy

Site Status

Ospedale Cà Foncello

Treviso, Veneto, Italy

Site Status

Ospedale Monaldi, UOC Clinica Pneumologica

Napoli, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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AIFA-ICSLIFE-001

Identifier Type: -

Identifier Source: org_study_id