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Pulmonary Disease, Chronic ObstructivePhase 4NCT03662711

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

A Phase 4 study testing Bronchodilator Agents in people with Pulmonary Disease, Chronic Obstructive, run by Università degli Studi di Ferrara at 39 sites in Italy.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
Bronchodilator Agents
Could I receive a placebo?
No, everyone receives an active treatment
How many people
843 participants
Where
39 sitesItaly
Study dates
11 Nov 2018to 26 Oct 2022
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant must be older than 60 years of age, at the time of signing the informed consent.
  • 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).
  • 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
  • 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
  • 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)
  • 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).
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  • 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.
  • Participant must be willing and able to perform pulmonary function tests
  • Male or female. Contraception is not considered necessary in this cohort of elderly (> 65 years) patients receiving treatment with commercially available licensed products.
  • 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.

Who cannot join

  • 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.)
  • Patients who required invasive mechanical ventilation during hospitalization
  • Patients with Asthma as primary and principal diagnosis
  • Patients with severe cardiovascular (CV) disease who in the opinion of the investigator are unlikely to survive the 15 month study period
  • 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)
  • Patients in whom spirometry is contraindicated (eg, hemoptysis, detached retina, active tuberculosis, last trimester of pregnancy)
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  • 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))
  • 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.
  • Participation in any other interventional study within the last 3 months or concurrent participation in an observational clinical study.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Italy39 sites

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

    Bari, BA

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

    Battipaglia, Campania, 84091

  • Ospedale Papa Giovanni XXIII

    Bergamo, Lombardy, 24127

  • Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa

    Cassano delle Murge, Apulia, 70020

  • Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele", Pneumologia

    Catania, Sicily, 95123

  • Dipartimento Di Scienze Mediche e Chirurgiche- Università Magna Grecia

    Catanzaro, Calabria, 88100

  • Ospedale Maggiore, Medicina interna

    Chieri, Piedmont, 10023

  • Ospedale Figlie di San Camillo, Medicina Interna

    Cremona, Lombardy, 26100

  • Ospedale San Giovanni di Dio, UOC Medicina Interna

    Crotone, Calabria, 88900

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

    Ferrara, FE, 44100

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

    Florence, Tuscany, 50134

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

    Florence, Tuscany, 50134

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

    Foggia, FG

  • Ospedale "Carlo Poma", Struttura Complessa Pneumologia e UTIR

    Mantua, Lombardy, 46100

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

    Milan, Lombardy, 20157

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

    Modena, Emilia-Romagna, 41124

  • Azienda Ospedaliera dei Colli - Ospedale Monaldi

    Naples, Campania, 80131

  • Ospedale Monaldi, UOC Clinica Pneumologica

    Naples

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

    Palermo, Pa, 90146

  • Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica

    Parma, Emilia-Romagna, 43126

  • Fondazione IRCCS Policlinico San Matteo, Pneumologia

    Pavia, Lombardy, 27100

  • Istituti Clinici Scientifici Fondazione Maugeri, Pneumologia Riabilitativa

    Pavia, Lombardy, 27100

  • ASL2 Savonese, Ospedale S. Corona, Pneumologia

    Pietra Ligure, Liguria, 17027

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

    Pordenone, Friuli Venezia Giulia, 33100

  • AUSL - IRCCS di Reggio Emilia, Pneumologia

    Reggio Emilia, Emilia-Romagna, 42122

  • Policlinico Universitario Campus Biomedico di Roma, Medicina Interna e Geriatria

    Rome, Lazio, 00128

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

    Rome, Lazio, 00133

  • Ospedale di Ceva, Medicina interna

    San Bernardino, Piedmont, 12073

  • Ospedale Civile SS. Annunziata, Medicina interna

    Savigliano, Piedmont, 12038

  • Ospedale San Paolo, Medicina 2 e cure Intermedie

    Savona, Liguria, 17100

  • Università degli studi di Siena, UOC Malattie respiratorie

    Siena, Tuscany, 53100

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

    Telese Terme, Benevento, 82037

  • Ospedali Riuniti di Ancona, Pneumologia

    Torrette, The Marches, 60030

  • Istituti Clinici Scientifici maugeri, Pneumologia Riabilitativa

    Tradate, Lombardy, 21049

  • Ospedale Cà Foncello

    Treviso, Veneto, 31100

  • Ospedale di Cattinara, unità operativa di pneumologia

    Trieste, TS

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

    Varese, Piedmont, 21100

  • Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa

    Veruno, Piedmont, 28010

  • Ospedale "Jazzolino" ASP, UOC Medicina Interna

    Vibo Valentia, Calabria, 89900

Other trials in Italy

About this study

Official title: 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).

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.

Read the 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.

Being tested
Bronchodilator Agents
Keywords
adult, drug therapy, combination, bronchodilator agents, male, female
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bronchodilator AgentsDrug

    Also called Revinty Ellipta

    Fluticasone furoate/vilanterol

  • Bronchodilator AgentsDrug

    Also called Spiriva Respimat

    Tiotropium

  • Bronchodilator AgentsDrug

    Also called Onbreez Brezhaler 150

    Indacaterol

  • Bronchodilator AgentsDrug

    Also called Laventair

    Umeclidinium/vilanterol

  • Bronchodilator AgentsDrug

    Also called Aliflus Diskus 50/500

    Fluticasone propionate/salmeterol

  • Bronchodilator AgentsDrug

    Also called Alabaster

    Beclometasone dipropionate/formoterol

  • Bronchodilator AgentsDrug

    Also called Fobuler

    Budesonide formoterol

  • Bronchodilator AgentsDrug

    Also called Tovanor Breezhaler

    Glycopyrronium

  • Bronchodilator AgentsDrug

    Also called Bretaris Genuair

    Aclidinium

  • Bronchodilator AgentsDrug

    Also called Incruse

    Umeclidinium

  • Bronchodilator AgentsDrug

    Also called Levovent

    Formoterol

  • Bronchodilator AgentsDrug

    Also called Ultibro Breezhaler

    Indacaterol glycopyrronium

  • Bronchodilator AgentsDrug

    Also called Serevent

    Salmeterol

  • Bronchodilator AgentsDrug

    Also called Spiolto Respimat

    Tiotropium olodaterol

  • Bronchodilator AgentsDrug

    Also called Duaklir Genuair

    Aclidinium/formoterol

  • Bronchodilator AgentsDrug

    Also called Striverdi Respimat

    Olodaterol

  • Bronchodilator AgentsDrug

    Also called Trimbow

    Formoterol/glycopyrronium bromide/beclometasone dipropionate

  • Bronchodilator AgentsDrug

    Also called Elebrato Ellipta

    Fluticasone furoate/umeclidinium bromide/vilanterol

Study groups in NCT03662711
Study groupRoleWhat they receive
Long-acting beta-agonist (LABA) or LABA/LAMAActive comparatorlong-acting bronchodilator agents (LABD, LAMA or LABA/LAMA) but no inhaled steroids plus usual care for comorbidities
Receives: Drug: Bronchodilator Agents
Long-acting muscarinic antagonist (LAMA) and/or LABA plus ICSExperimentalBronchodilator agents LAMA and/or LABA with inhaled steroids plus usual care for comorbidities
Receives: Drug: Bronchodilator Agents

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite event of the first time to first re-hospitalization and/or death (all cause)

    Measured: 12 months

Secondary outcomes (7)

  1. Number of moderate/severe COPD exacerbations in the two patient groups

    Measured: 12 months

  2. Number of re-hospitalizations and deaths (all cause) in the two patient groups

    Measured: 12 months

  3. Quality of life (QoL) variation measured as change in COPD Assessment Test (CAT) between the two patient groups

    Measured: 12 months

  4. QoL variation measured using modified Medical Research Council (mMRC) dyspnoea scale between the two patient groups

    Measured: 12 months

  5. Number of pneumonia events

    Measured: 12 months

  6. Number of acute cardiac events

    Measured: 12 months

  7. Number of cardiovascular events

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2018
  2. Study start11 Nov 2018
  3. Primary completion26 Oct 2022
  4. Study completion26 Oct 2022

Why it stopped: Contract terminated between AIFA and the Sponsor (University of Ferrara)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
843 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03662711
Sponsor's protocol ID
AIFA-ICSLIFE-001
Status last verified
Dec 2022
First submitted
28 Aug 2018
Last updated
28 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bronchodilator Agents in people with Pulmonary Disease, Chronic Obstructive, run by Università degli Studi di Ferrara at 39 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Contract terminated between AIFA and the Sponsor (University of Ferrara)). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite event of the first time to first re-hospitalization and/or death (all cause) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03662711.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2022.

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