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

NCT03662711 | Terminated Phase 4 DMC

• 1 other identifier: AIFA-ICSLIFE-001
• Study Type: interventional
• Target: 843
• Locations: 1 country
• Sites: 39

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

adult; drug therapy; combination; bronchodilator agents; male; female

Outcome Measures

Primary Outcomes (1)

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

  12 months

Secondary Outcomes (7)

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

  12 months

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

  12 months

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

  12 months

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

  12 months

• Number of pneumonia events

  12 months

Other Outcomes (2)

• Change in forced expiratory volume at one second (FEV1) from baseline to the end of treatment period

  12 months

• Change in forced vital capacity (FVC) from baseline to the end of treatment period

  12 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Bronchodilator Agents

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

EXPERIMENTAL

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

Drug: Bronchodilator Agents

Interventions

Bronchodilator Agents DRUG

Fluticasone furoate/vilanterol

Also known as: Revinty Ellipta

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

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• Università degli Studi di Ferrara: lead

Study Sites (39)

Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa

Cassano delle Murge, Apulia, 70020, Italy

Location

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

Bari, BA, Italy

Location

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

Telese Terme, Benevento, 82037, Italy

Location

Dipartimento Di Scienze Mediche e Chirurgiche- Università Magna Grecia

Catanzaro, Calabria, 88100, Italy

Location

Ospedale San Giovanni di Dio, UOC Medicina Interna

Crotone, Calabria, 88900, Italy

Location

Ospedale "Jazzolino" ASP, UOC Medicina Interna

Vibo Valentia, Calabria, 89900, Italy

Location

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

Battipaglia, Campania, 84091, Italy

Location

Azienda Ospedaliera dei Colli - Ospedale Monaldi

Napoli, Campania, 80131, Italy

Location

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

Modena, Emilia-Romagna, 41124, Italy

Location

Azienda Ospedaliero-universitaria di Parma, Clinica pneumologica

Parma, Emilia-Romagna, 43126, Italy

Location

AUSL - IRCCS di Reggio Emilia, Pneumologia

Reggio Emilia, Emilia-Romagna, 42122, Italy

Location

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

Ferrara, FE, 44100, Italy

Location

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

Foggia, FG, Italy

Location

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

Pordenone, Friuli Venezia Giulia, 33100, Italy

Location

Policlinico Universitario Campus Biomedico di Roma, Medicina Interna e Geriatria

Rome, Lazio, 00128, Italy

Location

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

Rome, Lazio, 00133, Italy

Location

ASL2 Savonese, Ospedale S. Corona, Pneumologia

Pietra Ligure, Liguria, 17027, Italy

Location

Ospedale San Paolo, Medicina 2 e cure Intermedie

Savona, Liguria, 17100, Italy

Location

Ospedale Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

Location

Ospedale Figlie di San Camillo, Medicina Interna

Cremona, Lombardy, 26100, Italy

Location

Ospedale "Carlo Poma", Struttura Complessa Pneumologia e UTIR

Mantova, Lombardy, 46100, Italy

Location

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

Milan, Lombardy, 20157, Italy

Location

Fondazione IRCCS Policlinico San Matteo, Pneumologia

Pavia, Lombardy, 27100, Italy

Location

Istituti Clinici Scientifici Fondazione Maugeri, Pneumologia Riabilitativa

Pavia, Lombardy, 27100, Italy

Location

Istituti Clinici Scientifici maugeri, Pneumologia Riabilitativa

Tradate, Lombardy, 21049, Italy

Location

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

Palermo, Pa, 90146, Italy

Location

Ospedale Maggiore, Medicina interna

Chieri, Piedmont, 10023, Italy

Location

Ospedale di Ceva, Medicina interna

San Bernardino, Piedmont, 12073, Italy

Location

Ospedale Civile SS. Annunziata, Medicina interna

Savigliano, Piedmont, 12038, Italy

Location

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

Varese, Piedmont, 21100, Italy

Location

Istituti Clinici Scientifici Maugeri, Pneumologia Riabilitativa

Veruno, Piedmont, 28010, Italy

Location

Azienda Ospedaliero Universitaria "Policlinico Vittorio Emanuele", Pneumologia

Catania, Sicily, 95123, Italy

Location

Ospedali Riuniti di Ancona, Pneumologia

Torrette, The Marches, 60030, Italy

Location

Ospedale di Cattinara, unità operativa di pneumologia

Trieste, TS, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

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

Florence, Tuscany, 50134, Italy

Location

Università degli studi di Siena, UOC Malattie respiratorie

Siena, Tuscany, 53100, Italy

Location

Ospedale Cà Foncello

Treviso, Veneto, 31100, Italy

Location

Ospedale Monaldi, UOC Clinica Pneumologica

Napoli, Italy

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Bronchodilator Agents; Calcium Sulfate; GSK573719; Salmeterol Xinafoate; tiotropium-olodaterol; olodaterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Asthmatic Agents; Respiratory System Agents; Therapeutic Uses; Calcium Compounds; Inorganic Chemicals; Minerals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: September 7, 2018
• Study Start: November 11, 2018
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: December 28, 2022

Record last verified: 2022-12

Locations

IT (39)