Morphological Parameters of Blood Cell's Activation in Characterization and Prognosis in a COPD Patients Cohort

NCT04923360 | Unknown

• 1 other identifier: G95756334
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Though exacerbations in the COPD (Chronic Pulmonary Obstructive Disease) and specially the most severe cases (hospitalizations) are currently a fundamental outcome in the COPD due to its clinical and economic significance, there are many unanswered questions still today such as the very definition of exacerbation itself. Research parameters like the CPD (Cell Population Data) are added to the basic blood count. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) provide quantitative information of the morphological and functional characteristics of the leukocytes: their volume, content of nucleic acids and structure of the cytoplasm. The CPD are numerical data which represent the morphology which characterizes the neutrophils, lymphocytes, monocytes, eosinophils and platelets classifying them as per their volume and shape, granularity and their content of nucleic acids. The approach is that such cheap and accessible technique can provide relevant information in the area of COPD exacerbations. Therefore, this study proposes several objectives:

1. 1.Establish the CPD values for each phenotype of COPD (both for those already established in the Spanish guide of COPD and in the potential phenotypes which may be established in this study based on the CPDs themselves).
2. 2.Identify which, among the CPDs, are more relevant in relation to cellular activation (neutrophils, lymphocytes, eosinophils and platelets) both in the stage of clinical stability and during the severe exacerbation.
3. 3.Establish different phenotypes of COPD (in stable phase) according to the CPD values.
4. 4.Determine the existence of an association between the level of activation of these cells in stability phase of the COPD and the risk of exacerbation; establish the optimum cutoff points.

Conditions

COPD

Keywords

COPD prognostic; COPD characterization; Cellular Popular Data

Outcome Measures

Primary Outcomes (1)

• Establish CPD (Cellular Popular Data) values for each phenotype of COPD.

  * CPD (Cellular Popular Data): morphological parameters measured in the blood count cells (neutrophils, lymphocytes, eosinophils and platelets). * Phenotypes of COPD described in Spanish COPD guideline (GesEPOC): * No exacerbator: patient with 0-1 exacerbation per year, without admission * Exacerbator with emphysema: patient with emphysema and 2 or more exacerbations per year or 1 admission * Exacerbator with chronic bronchitis: patient with chronic bronchitis and 2 or more exacerbations per year or 1 admission * Mixed phenotype: asthma-COPD overlap: a patient with COPD and diagnostic criteria for asthma, or with a very positive bronchodilator test (increase in FEV1\> 400ml and 15%) and / or peripheral blood eosinophilia greater than 300cells / mm3.

  3 years

Secondary Outcomes (3)

• Identify which, among the CPDs, are more relevant in relation to cellular activation (neutrophils, lymphocytes, eosinophils and platelets) both in the stage of clinical stability and during the severe exacerbation.

  3 years

• Establish new phenotypes of COPD

  3 years

• Determine the existence of an association between the level of activation of these cells in stability phase of COPD and the risk of exacerbation

  3 years

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with COPD diagnosis following American Thoracic Association (Am Rev Respir Dis 1987;136:225-244), FEV1/FVC \< 70% post-bronchodilator. The diagnosis of COPD and the treatment must be at least 6 months before the inclusion in the study.

You may qualify if:

• COPD diagnosis following American Thoracic Association (Am Rev Respir Dis 1987;136:225-244), FEV1/FVC \< 70% (FEV1: forced expiratory volume in one second, FVC: forced vital capacity) post-bronchodilator. Acceptation to participate in the study by the informed consent.

You may not qualify if:

• Concomitant diseases that could interfere in the realization of the measures in the study (dementia, severe psychiatric disease, invalidating neurological diseases, important deafness, active neoplasms); patients with asthma as main diagnostic; patients with bronchiectasis as main disease or with extensive sequels of pulmonary tuberculosis; patients that in the beginning seem to be unable to follow the procedures of the study (questionnaires, pulmonary function test, 6 minutes walking test…); patients with difficulties to walk; patients with active infections or chronic inflammatory diseases; patients that reuse to participate in the study.

Sponsors & Collaborators

• Hospital Galdakao-Usansolo: lead
• Osakidetza: collaborator

Study Sites (1)

Hospital Galdakao Usansolo

Galdakao, Vizcaya, 48960, Spain

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Inflammation markers

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Cristobal Esteban, MD

  Osakidetza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristobal Esteban, MD

CONTACT

+34 94 400 7002; cristobal.est@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 11, 2021
• First Posted: June 11, 2021
• Study Start: January 1, 2018
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 11, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)