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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03662711
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : June 11, 2020
Information provided by (Responsible Party):
Alberto Papi, MD, Università degli Studi di Ferrara

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
Pulmonary Disease, Chronic Obstructive 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% ( 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 11, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

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
Other Name: Spiriva Respimat

Drug: Bronchodilator Agents
Other Name: Onbreez Brezhaler 150

Drug: Bronchodilator Agents
Other Name: Laventair

Drug: Bronchodilator Agents
Other Name: Tovanor Breezhaler

Drug: Bronchodilator Agents
Other Name: Bretaris Genuair

Drug: Bronchodilator Agents
Other Name: Incruse

Drug: Bronchodilator Agents
Other Name: Levovent

Drug: Bronchodilator Agents
Indacaterol glycopyrronium
Other Name: Ultibro Breezhaler

Drug: Bronchodilator Agents
Other Name: Serevent

Drug: Bronchodilator Agents
Tiotropium olodaterol
Other Name: Spiolto Respimat

Drug: Bronchodilator Agents
Other Name: Duaklir Genuair

Drug: Bronchodilator Agents
Other Name: 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 Name: Revinty Ellipta

Drug: Bronchodilator Agents
Fluticasone propionate/salmeterol
Other Name: Aliflus Diskus 50/500

Drug: Bronchodilator Agents
Beclometasone dipropionate/formoterol
Other Name: Alabaster

Drug: Bronchodilator Agents
Budesonide formoterol
Other Name: Fobuler

Drug: Bronchodilator Agents
Formoterol/glycopyrronium bromide/beclometasone dipropionate
Other Name: Trimbow

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

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

Secondary Outcome Measures :
  1. Number of moderate/severe COPD exacerbations in the two patient groups [ Time Frame: 12 months ]
  2. Number of re-hospitalizations and deaths (all cause) in the two patient groups [ Time Frame: 12 months ]
  3. Quality of life (QoL) variation measured as change in COPD Assessment Test (CAT) between the two patient groups [ Time Frame: 12 months ]
  4. QoL variation measured using modified Medical Research Council (mMRC) dyspnoea scale between the two patient groups [ Time Frame: 12 months ]
  5. Number of pneumonia events [ Time Frame: 12 months ]
  6. Number of acute cardiac events [ Time Frame: 12 months ]
  7. Number of cardiovascular events [ Time Frame: 12 months ]

Other Outcome Measures:
  1. Change in forced expiratory volume at one second (FEV1) from baseline to the end of treatment period [ Time Frame: 12 months ]
  2. Change in forced vital capacity (FVC) from baseline to the end of treatment period [ Time Frame: 12 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03662711

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Contact: Alberto Papi, MD +039 0532 210420
Contact: Fabio Gambini +039 045 8202666

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Sponsors and Collaborators
Università degli Studi di Ferrara
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Responsible Party: Alberto Papi, MD, Professor, Università degli Studi di Ferrara Identifier: NCT03662711    
Other Study ID Numbers: AIFA-ICSLIFE-001
First Posted: September 7, 2018    Key Record Dates
Last Update Posted: June 11, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alberto Papi, MD, Università degli Studi di Ferrara:
drug therapy
bronchodilator agents
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents