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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

Sponsor
Università degli Studi di Ferrara (Other)
Overall Status
Recruiting
CT.gov ID
NCT03662711
Collaborator
(none)
1,032
Enrollment
42
Locations
2
Arms
51.6
Anticipated Duration (Months)
24.6
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
  • Drug: Bronchodilator Agents
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
1032 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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).
Actual Study Start Date :
Nov 11, 2018
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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
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
    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

    		•
    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
    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
    Formoterol/glycopyrronium bromide/beclometasone dipropionate
    Other Names:
  • Trimbow

    • Drug: Bronchodilator Agents
    Fluticasone furoate/umeclidinium bromide/vilanterol
    Other Names:
  • Elebrato Ellipta

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Composite event of the first time to first re-hospitalization and/or death (all cause) [12 months]

    Secondary Outcome Measures

    1. Number of moderate/severe COPD exacerbations in the two patient groups [12 months]

    2. Number of re-hospitalizations and deaths (all cause) in the two patient groups [12 months]

    3. Quality of life (QoL) variation measured as change in COPD Assessment Test (CAT) between the two patient groups [12 months]

    4. QoL variation measured using modified Medical Research Council (mMRC) dyspnoea scale between the two patient groups [12 months]

    5. Number of pneumonia events [12 months]

    6. Number of acute cardiac events [12 months]

    7. Number of cardiovascular events [12 months]

    Other Outcome Measures

    1. Change in forced expiratory volume at one second (FEV1) from baseline to the end of treatment period [12 months]

    2. Change in forced vital capacity (FVC) from baseline to the end of treatment period [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Policlinico di Bari, U.O.C. Malattie dell'Apparato Respiratorio Universitaria Bari BA Italy
    2 Istituti Clinici Scientifici Maugeri S.p.A - SB, Pneumologia Riabilitativa Telese Terme Benevento Italy 82037
    3 Dipartimento Di Scienze Mediche e Chirurgiche- Università Magna Grecia Catanzaro Calabria Italy 88100
    4 Ospedale San Giovanni di Dio, UOC Medicina Interna Crotone Calabria Italy 88900
    5 Ospedale "Jazzolino" ASP, UOC Medicina Interna Vibo Valentia Calabria Italy 89900
    6 Ospedale civile di Battipaglia, Medicina, Servizio di Allergologia e Immunologia Clinica Battipaglia Campania Italy 84091
    7 Azienda Ospedaliera dei Colli - Ospedale Monaldi Napoli Campania Italy 80131
    8 Università degli studi di Modena e Reggio Emilia, Clinica Malattie dell'apparato Respiratorio Modena Emilia Romagna Italy 41124
    9 Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica Parma Emilia Romagna Italy 43126
    10 AUSL - IRCCS di Reggio Emilia, Pneumologia Reggio Emilia Emilia Romagna Italy 42122
    11 UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO Ferrara FE Italy 44100
    12 Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio Foggia FG Italy
    13 Ospedale S. Maria degli Angeli - AAS5 Friuli Occidentale, Pneumologia Pordenone Friuli Venezia Giulia Italy 33100
    14 Policlinico Universitario Campus Biomedico di Roma, Medicina Interna e Geriatria Roma Lazio Italy 00128
    15 Università di Roma "Tor Vergata", Dipartimento di Medicina dei Sistemi, Malattie dell'apparato respiratorio Roma Lazio Italy 00133
    16 ASL2 Savonese, Ospedale S. Corona, Pneumologia Pietra Ligure Liguria Italy 17027
    17 Ospedale San Paolo, Medicina 2 e cure Intermedie Savona Liguria Italy 17100
    18 Ospedale Papa Giovanni XXIII Bergamo Lombardia Italy 24127
    19 Ospedale Figlie di San Camillo, Medicina Interna Cremona Lombardia Italy 26100
    20 ASST Ovest Milanese - Ospedale civile di Legnano, Medicina interna Legnano Lombardia Italy 20025
    21 ASST Ospedale Maggiore di Lodi Lodi Lombardia Italy 26900
    22 Ospedale "Carlo Poma", Struttura Complessa Pneumologia e UTIR Mantova Lombardia Italy 46100
    23 Ospedale "L. Sacco" - Polo Universitario ASST Fatebenefratelli Sacco, Pneumologia Milano Lombardia Italy 20157
    24 Fondazione IRCCS Policlinico San Matteo, Pneumologia Pavia Lombardia Italy 27100
    25 Istituti Clinici Scientifici Fondazione Maugeri, Pneumologia Riabilitativa Pavia Lombardia Italy 27100
    26 Istituti Clinici Scientifici maugeri, Pneumologia Riabilitativa Tradate Lombardia Italy 21049
    27 Ospedali Riuniti di Ancona, Pneumologia Torrette Marche Italy 60030
    28 Università degli Studi di Palermo, Ospedale "V. Cervello" Palermo Pa Italy 90146
    29 Università degli studi di Padova, dipartimento di Pneunmologia Padova PD Italy
    30 Ospedale Maggiore, Medicina interna Chieri Piemonte Italy 10023
    31 Ospedale di Ceva, Medicina interna San Bernardino Piemonte Italy 12073
    32 Ospedale Civile SS. Annunziata, Medicina interna Savigliano Piemonte Italy 12038
    33 Policlinico Ospedaliero di Varese - Ospedale di Circolo e Fondazione Macchi, Medicina interna Varese Piemonte Italy 21100
    34 Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa Veruno Piemonte Italy 28010
    35 Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa Cassano Delle Murge Puglia Italy 70020
    36 Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele", Pneumologia Catania Sicilia Italy 95123
    37 Azienda Ospedaliero-universitaria Careggi, Medicina per la alta complessità Assistenziale 1 Firenze Toscana Italy 50134
    38 Azienda Ospedaliero-universitaria Careggi, Medicina per la alta complessità Assistenziale 2 Firenze Toscana Italy 50134
    39 Università degli studi di Siena, UOC Malattie respiratorie Siena Toscana Italy 53100
    40 Ospedale di Cattinara, unità operativa di pneumologia Trieste TS Italy
    41 Ospedale Cà Foncello Treviso Veneto Italy 31100
    42 Ospedale Monaldi, UOC Clinica Pneumologica Napoli Italy

    Sponsors and Collaborators

    • Università degli Studi di Ferrara

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alberto Papi, MD, Professor, Università degli Studi di Ferrara
    ClinicalTrials.gov Identifier:
    NCT03662711
    Other Study ID Numbers:
    • AIFA-ICSLIFE-001
    First Posted:
    Sep 7, 2018
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Sep 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Alberto Papi, MD, Professor, Università degli Studi di Ferrara
    adult
    drug therapy
    combination
    bronchodilator agents
    male
    female
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Obstructive
    Pulmonary Disease, Chronic Obstructive
    Bronchodilator Agents
    Olodaterol

    Study Results

    No Results Posted as of Oct 7, 2021