The Italian Registry of Patients With Chronic Obstructive Pulmonary Disease

NCT06652776 | Enrolling By Invitation DMC

• 1 other identifier: 20-27Sept2023
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic obstructive pulmonary disease (COPD) is a treatable but debilitating medical condition associated with persistent symptoms and chronic airflow obstruction. Despite the availability of multiple therapeutic options, COPD is the third leading cause of death worldwide and has a substantial socioeconomic impact. The present real life study is aimed at describing the clinical and functional characteristics, treatment patterns, impact of exacerbations and comorbidities and their association with mortality in a large cohort of Italian patients with COPD.

Conditions

COPD; COPD Exacerbation Acute; Comorbid Chronic Lung Disease on Heart Failure; Mortality; Cardiovascular Diseases; Cardiovascular Events; COPD Prevalance

Keywords

COPD; AECOPD; Mortality in AECOPD; COPD mortality risk factors; COPD prevalence; lung function; emphysema; chronic bronchitis; COPD hospitalization; heart failure; cardiovascular mortality; Bronchodilators; COPD therapy; triple therapy

Outcome Measures

Primary Outcomes (2)

• All cause mortality

  Annual all-cause mortality rate

  From index date (registry inclusion) until the date of death from any cause, assessed up to 120 months

• Burden of moderate and severe COPD acute exacerbations

  Incidence and annual rate of moderate and/or severe exacerbations

  From index date (registry inclusion) until the date of first event of moderate or severe exacerbation, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months

Secondary Outcomes (6)

• Cardiovascular mortality

  From index date (registry inclusion) until the date of death provoked by a cardiovascular event, assessed up to 120 months

• Cardiovascular comorbidities

  At index date (registry inclusion) comorbidities will be registered and updated at every new visit until patient's death

• Cardiovascular events

  From index date (registry inclusion) until the date of any cardiovascular event or cardiovascular death, whichever comes first, assessed up to 120 months

• Lung function decline

  From index date (registry inclusion) until the date of the first lung function test, and any following available lung function assessment, or the date of patient's death, whichever comes first, assessed up to 120 months

• Eosinophil count

  From index date (registry inclusion) until the date of first available eosinophil count, and any following point in time with available eosinophil count updates, or patients' death, whichever comes first, assessed up to 120 months

Other Outcomes (6)

• Exacerbation etiology

  From index date (registry inclusion) until the date of the first available acute exacerbation of any severity, and any following event of modand any following exacerbation event date, or patient 's death, whichever comes first, assessed up to 120 months

• Corticosteroid treatment during COPD exacerbation

  From index date (registry inclusion) until the date of first exacerbation of any severity, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months.

• Antibiotic treatments during acute COPD exacerbations

  From index date (registry inclusion) until the date of first exacerbation of any severity, and any following event of moderate or severe exacerbation, or patient's death, whichever comes first, assessed up to 120 months.

Study Arms (1)

COPD patients

All patients with a functionally confirmed diagnosis of COPD

Other: Pharmacological treatment

Interventions

Pharmacological treatment OTHER

Pharmacological and non pharmacological treatments will be assessed and monitored during the retrospective and prospective phase, and will include: * bronchodilators, inhaled steroids and their combinations * mucolytics * biologic therapies for COPD * roflumilast * pulmonary rehabilitation

COPD patients

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with functionally confirmed COPD and a track medical record in the 12 months before enrollment

You may qualify if:

• established diagnosis of COPD (defined as age ≥ 40 years old, smoking history ≤ 20 pack years, postbronchodilator forced expiratory volume in one second to slow vital capacity ratio (FEV1/VC) ≤ the lower limit of normal (LLN) criteria.

You may not qualify if:

• Presence of current clinically significant asthma
• Diagnosis or clinically significant alternative respiratory diseases (such as interstitial lung disease or bronchiectasis)

Sponsors & Collaborators

• University of Pavia: collaborator
• Azienda Ospedaliera Universitaria Integrata Verona: collaborator
• University Magna Graecia: collaborator
• University of Rome Tor Vergata: collaborator
• University of Palermo: collaborator
• University of Turin, Italy: collaborator
• University Hospital of Ferrara: collaborator
• Università degli Studi di Sassari: collaborator
• Italian Association of Hospital Pneumologists: collaborator
• University of Milan: lead
• University of Genova: collaborator
• University Hospital Verona, Italy: collaborator
• Societa Italiana di Pneumologia: collaborator

Study Sites (1)

Luigi Sacco University Hospital, Division of Department of Biomedical and Clinical Sciences, University of Milan

Milan, Milan, 20157, Italy

Location

Related Publications (2)

• Santus P, Di Marco F, Braido F, Contoli M, Corsico AG, Micheletto C, Pelaia G, Radovanovic D, Rogliani P, Saderi L, Scichilone N, Tanzi S, Vella M, Boarino S, Sotgiu G, Solidoro P. Exacerbation Burden in COPD and Occurrence of Mortality in a Cohort of Italian Patients: Results of the Gulp Study. Int J Chron Obstruct Pulmon Dis. 2024 Mar 1;19:607-618. doi: 10.2147/COPD.S446636. eCollection 2024.

  PMID: 38444551 BACKGROUND

• Radovanovic D, Contoli M, Marco FD, Sotgiu G, Pelaia G, Braido F, Corsico AG, Micheletto C, Rogliani P, Scichilone N, Saderi L, Santus P, Solidoro P. Clinical and Functional Characteristics of COPD Patients Across GOLD Classifications: Results of a Multicenter Observational Study. COPD. 2019 Aug;16(3-4):215-226. doi: 10.1080/15412555.2019.1659760. Epub 2019 Sep 9.

  PMID: 31500459 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Emphysema; Bronchitis, Chronic; Heart Failure

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 22, 2024
• Study Start: September 30, 2024
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: May 4, 2026

Record last verified: 2026-01

Locations

IT (1)