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

December 15, 2022 updated by: Alberto Papi, MD, Università degli Studi di Ferrara

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

843

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Napoli, Italy
        • Ospedale Monaldi, UOC Clinica Pneumologica
    • BA
      • Bari, BA, Italy
        • Policlinico di Bari, U.O.C. Malattie dell'Apparato Respiratorio Universitaria
    • Benevento
      • Telese Terme, Benevento, Italy, 82037
        • Istituti Clinici Scientifici Maugeri S.p.A - SB, Pneumologia Riabilitativa
    • Calabria
      • Catanzaro, Calabria, Italy, 88100
        • Dipartimento Di Scienze Mediche e Chirurgiche- Università Magna Grecia
      • Crotone, Calabria, Italy, 88900
        • Ospedale San Giovanni di Dio, UOC Medicina Interna
      • Vibo Valentia, Calabria, Italy, 89900
        • Ospedale "Jazzolino" ASP, UOC Medicina Interna
    • Campania
      • Battipaglia, Campania, Italy, 84091
        • Ospedale civile di Battipaglia, Medicina, Servizio di Allergologia e Immunologia Clinica
      • Napoli, Campania, Italy, 80131
        • Azienda Ospedaliera dei Colli - Ospedale Monaldi
    • Emilia Romagna
      • Modena, Emilia Romagna, Italy, 41124
        • Università degli studi di Modena e Reggio Emilia, Clinica Malattie dell'apparato Respiratorio
      • Parma, Emilia Romagna, Italy, 43126
        • Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica
      • Reggio Emilia, Emilia Romagna, Italy, 42122
        • AUSL - IRCCS di Reggio Emilia, Pneumologia
    • FE
      • Ferrara, FE, Italy, 44100
        • UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO
    • FG
      • Foggia, FG, Italy
        • Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio
    • Friuli Venezia Giulia
      • Pordenone, Friuli Venezia Giulia, Italy, 33100
        • Ospedale S. Maria degli Angeli - AAS5 Friuli Occidentale, Pneumologia
    • Lazio
      • Roma, Lazio, Italy, 00128
        • Policlinico Universitario Campus Biomedico di Roma, Medicina Interna e Geriatria
      • Roma, Lazio, Italy, 00133
        • Università di Roma "Tor Vergata", Dipartimento di Medicina dei Sistemi, Malattie dell'apparato respiratorio
    • Liguria
      • Pietra Ligure, Liguria, Italy, 17027
        • ASL2 Savonese, Ospedale S. Corona, Pneumologia
      • Savona, Liguria, Italy, 17100
        • Ospedale San Paolo, Medicina 2 e cure Intermedie
    • Lombardia
      • Bergamo, Lombardia, Italy, 24127
        • Ospedale Papa Giovanni XXIII
      • Cremona, Lombardia, Italy, 26100
        • Ospedale Figlie di San Camillo, Medicina Interna
      • Mantova, Lombardia, Italy, 46100
        • Ospedale "Carlo Poma", Struttura Complessa Pneumologia e UTIR
      • Milano, Lombardia, Italy, 20157
        • Ospedale "L. Sacco" - Polo Universitario ASST Fatebenefratelli Sacco, Pneumologia
      • Pavia, Lombardia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo, Pneumologia
      • Pavia, Lombardia, Italy, 27100
        • Istituti Clinici Scientifici Fondazione Maugeri, Pneumologia Riabilitativa
      • Tradate, Lombardia, Italy, 21049
        • Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa
    • Marche
      • Torrette, Marche, Italy, 60030
        • Ospedali Riuniti di Ancona, Pneumologia
    • Pa
      • Palermo, Pa, Italy, 90146
        • Università degli Studi di Palermo, Ospedale "V. Cervello"
    • Piemonte
      • Chieri, Piemonte, Italy, 10023
        • Ospedale Maggiore, Medicina interna
      • San Bernardino, Piemonte, Italy, 12073
        • Ospedale di Ceva, Medicina interna
      • Savigliano, Piemonte, Italy, 12038
        • Ospedale Civile SS. Annunziata, Medicina interna
      • Varese, Piemonte, Italy, 21100
        • Policlinico Ospedaliero di Varese - Ospedale di Circolo e Fondazione Macchi, Medicina interna
      • Veruno, Piemonte, Italy, 28010
        • Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa
    • Puglia
      • Cassano Delle Murge, Puglia, Italy, 70020
        • Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa
    • Sicilia
      • Catania, Sicilia, Italy, 95123
        • Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele", Pneumologia
    • TS
      • Trieste, TS, Italy
        • Ospedale di Cattinara, unità operativa di pneumologia
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliero-universitaria Careggi, Medicina per la alta complessità Assistenziale 1
      • Firenze, Toscana, Italy, 50134
        • Azienda Ospedaliero-universitaria Careggi, Medicina per la alta complessità Assistenziale 2
      • Siena, Toscana, Italy, 53100
        • Università degli studi di Siena, UOC Malattie respiratorie
    • Veneto
      • Treviso, Veneto, Italy, 31100
        • Ospedale Ca Foncello

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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
Drug: Bronchodilator Agents
Fluticasone furoate/vilanterol
Other Names:
  • Revinty Ellipta
Drug: Bronchodilator Agents
Tiotropium
Other Names:
  • Spiriva Respimat
Drug: Bronchodilator Agents
Indacaterol
Other Names:
  • Onbreez Brezhaler 150
Drug: Bronchodilator Agents
Umeclidinium/vilanterol
Other Names:
  • Laventair
Drug: Bronchodilator Agents
Fluticasone propionate/salmeterol
Other Names:
  • Aliflus Diskus 50/500
Drug: Bronchodilator Agents
Beclometasone dipropionate/formoterol
Other Names:
  • Alabaster
Drug: Bronchodilator Agents
Budesonide formoterol
Other Names:
  • Fobuler
Drug: Bronchodilator Agents
Glycopyrronium
Other Names:
  • Tovanor Breezhaler
Drug: Bronchodilator Agents
Aclidinium
Other Names:
  • Bretaris Genuair
Drug: Bronchodilator Agents
Umeclidinium
Other Names:
  • Incruse
Drug: Bronchodilator Agents
Formoterol
Other Names:
  • Levovent
Drug: Bronchodilator Agents
Indacaterol glycopyrronium
Other Names:
  • Ultibro Breezhaler
Drug: Bronchodilator Agents
Salmeterol
Other Names:
  • Serevent
Drug: Bronchodilator Agents
Tiotropium olodaterol
Other Names:
  • Spiolto Respimat
Drug: Bronchodilator Agents
Aclidinium/formoterol
Other Names:
  • Duaklir Genuair
Drug: Bronchodilator Agents
Olodaterol
Other Names:
  • Striverdi Respimat
Drug: Bronchodilator Agents
Formoterol/glycopyrronium bromide/beclometasone dipropionate
Other Names:
  • Trimbow
Drug: Bronchodilator Agents
Fluticasone furoate/umeclidinium bromide/vilanterol
Other Names:
  • Elebrato Ellipta
Experimental: Long-acting muscarinic antagonist (LAMA) and/or LABA plus ICS
Bronchodilator agents LAMA and/or LABA with inhaled steroids plus usual care for comorbidities
Drug: Bronchodilator Agents
Fluticasone furoate/vilanterol
Other Names:
  • Revinty Ellipta
Drug: Bronchodilator Agents
Tiotropium
Other Names:
  • Spiriva Respimat
Drug: Bronchodilator Agents
Indacaterol
Other Names:
  • Onbreez Brezhaler 150
Drug: Bronchodilator Agents
Umeclidinium/vilanterol
Other Names:
  • Laventair
Drug: Bronchodilator Agents
Fluticasone propionate/salmeterol
Other Names:
  • Aliflus Diskus 50/500
Drug: Bronchodilator Agents
Beclometasone dipropionate/formoterol
Other Names:
  • Alabaster
Drug: Bronchodilator Agents
Budesonide formoterol
Other Names:
  • Fobuler
Drug: Bronchodilator Agents
Glycopyrronium
Other Names:
  • Tovanor Breezhaler
Drug: Bronchodilator Agents
Aclidinium
Other Names:
  • Bretaris Genuair
Drug: Bronchodilator Agents
Umeclidinium
Other Names:
  • Incruse
Drug: Bronchodilator Agents
Formoterol
Other Names:
  • Levovent
Drug: Bronchodilator Agents
Indacaterol glycopyrronium
Other Names:
  • Ultibro Breezhaler
Drug: Bronchodilator Agents
Salmeterol
Other Names:
  • Serevent
Drug: Bronchodilator Agents
Tiotropium olodaterol
Other Names:
  • Spiolto Respimat
Drug: Bronchodilator Agents
Aclidinium/formoterol
Other Names:
  • Duaklir Genuair
Drug: Bronchodilator Agents
Olodaterol
Other Names:
  • Striverdi Respimat
Drug: Bronchodilator Agents
Formoterol/glycopyrronium bromide/beclometasone dipropionate
Other Names:
  • Trimbow
Drug: Bronchodilator Agents
Fluticasone furoate/umeclidinium bromide/vilanterol
Other Names:
  • Elebrato Ellipta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Composite event of the first time to first re-hospitalization and/or death (all cause)
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of moderate/severe COPD exacerbations in the two patient groups
Time Frame: 12 months
12 months
Number of re-hospitalizations and deaths (all cause) in the two patient groups
Time Frame: 12 months
12 months
Quality of life (QoL) variation measured as change in COPD Assessment Test (CAT) between the two patient groups
Time Frame: 12 months
12 months
QoL variation measured using modified Medical Research Council (mMRC) dyspnoea scale between the two patient groups
Time Frame: 12 months
12 months
Number of pneumonia events
Time Frame: 12 months
12 months
Number of acute cardiac events
Time Frame: 12 months
12 months
Number of cardiovascular events
Time Frame: 12 months
12 months

Other Outcome Measures

Outcome Measure
Time Frame
Change in forced expiratory volume at one second (FEV1) from baseline to the end of treatment period
Time Frame: 12 months
12 months
Change in forced vital capacity (FVC) from baseline to the end of treatment period
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università degli Studi di Ferrara

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2018

Primary Completion (Actual)

October 26, 2022

Study Completion (Actual)

October 26, 2022

Study Registration Dates

First Submitted

August 28, 2018

First Submitted That Met QC Criteria

September 5, 2018

First Posted (Actual)

September 7, 2018

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 15, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIFA-ICSLIFE-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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