COPDNCT04923360
Morphological Parameters of Blood Cell's Activation in Characterization and Prognosis in a COPD Patients Cohort
An observational study of COPD, run by Hospital Galdakao-Usansolo at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COPD
- How many people
- 500 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2018to 1 Jun 2022
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Galdakao Usansolo
Galdakao, Vizcaya, 48960
Cristobal Esteban, MD, +34-944007002, cristobal.est@gmail.com
About this study
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.
Read more
Therefore, this study proposes several objectives:
- 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).
- 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.
- Establish different phenotypes of COPD (in stable phase) according to the CPD values.
- 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.
The study will include 500 patients with different levels of COPD in the OSI-Barrualde and OSI-Bilbao. Several clinical measurements will be carried out for their characterization. CPD measurements will be made both in clinical stability phase or during exacerbations.
Read the detailed description
One of the most analyzed outcomes in COPD (Chronic Pulmonary Obstructive Disease) are the exacerbations, specially the severe ones. There are two challenges in relation to severe exacerbations: one related to the high use of sanitary resources and costs; and the second one, related to the worsening of the pulmonary function and the quality of life.
Nowadays in the Spanish COPD guideline called GESEPOC (Guía Española de la Enfermedad Pulmonar Obstructiva Crónica), there is a COPD "exacerbator" phenotype. However, there are some limitations round the COPD exacerbation, like its definition or its predictors. In other words, there are no indicators that can help the investigators to define more precisely an exacerbation or the COPD exacerbator profile.
COPD is a chronic disease with low intensity, systemic and chronic inflammation. The matter is that it is not established which indicators the investigators have to use to determinate it. There are some indicators like C reactive protein, TNF-alpha, IL-6 (Interleukin 6), microalbumins and adiponectin; and there are also prognostic scores based on them. However, they cannot help the investigators to establish COPD phenotypes of patients that can suffer an exacerbation. The investigators neither have indicators in stable phase that say them the risk of an exacerbation. Moreover, it is said that there are different types of exacerbations and even it has been established indicators of these exacerbation phenotypes. However, nowadays it cannot be translated into daily clinical practice. If investigators would be able to do it, they could advance in the knowledge of the exacerbations and they could establish precision treatments.
The blood count is one of the most required laboratory test in clinical practice. It is cost-effective because of its low price and the huge quantity of information it brings. After adapting the flow cytometry in hematologic modern analyzers, a more detailed study of cells can be done. Moreover, morphological changes can be detected in response to different stimulus, like infections or the ones that are caused by inflammatory reactions.
In this project, CPD ("Cellular Popular Data") is added to the basis blood count. They are parameters that are under investigation nowadays. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) give quantitative information about morphological and functional characteristics of leukocytes: their volume, the quantity of nucleic acid they contain and the structure of the cytoplasm. The CPD are numeric data that represent the morphology of the neutrophils, lymphocytes, monocytes and eosinophils, and they classify them by their volume, form, granularity and nucleic acid content. The same technology allows to the analyzer to classify the platelets by their morphology, what is related to its thrombogenic activity.
The composition of the membrane of the activated cells is different from the one of cells that are at rest, because of the expression of the receptors and the surface signaling molecules, in response to the activation. This membrane is more sensitive to the reagents of the analyzer, and more quantity of fluorescent colorant can enter in the activated cell and link to the cytoplasmic organelles and nucleic acids. The optic signals are different, what allows to distinguish morphological changes, and they are directly related to the cell functionality.
The activated neutrophils and monocytes have more "deformability", mobility and more capacity to adhesion, granulation and liberation of cytokines.
CPD values reflect morphological and functional transformation of these activated cells, and they give us very important information of the state of the cell and the state of the patient at the moment the sample is taken.
In addition, CPD support the differentiation between viral and bacterial infections or between acute and chronic infections, but also they say if there is an inflammatory condition without infection, with better diagnostic performance than conventional parameters, like total leukocytes, neutrophiles percentage and C reactive protein, that traditionally are used like acute infection markers.
Currently available literature speaks about the utility of CPD in the diagnosis, but there is no data about their possible prognostic value.
Respect from blood cells, previous COPD studies showed the relation between neutrophils/lymphocytes and platelets/lymphocytes as prognostic factors during severe exacerbations in COPD. Nowadays, it is emphasized the importance of eosinophils in COPD like predictor of exacerbation, like exacerbation severity marker and like response marker to the treatment in stable and in the exacerbation phase. It is thought that in this study the prognostic capacity of these new approaches can be better, becauseit is included the grade of activation of these cells like key parameter. This is a novel approach in the COPD field.
On the other hand, other inflammatory biomarkers (TNF-alpha, IL-6…) are expensive and less accessible in the daily clinical practice, while the evaluation of these new biomarkers of leukocytes are cheaper and more available in routine clinical practice by the blood count.
These new biomarkers could help the investigators confirming the inflammatory response and recognizing patients that could exacerbate. They also could determine the kind of their exacerbation and their prognosis.
- Conditions
- COPD
- Keywords
- COPD prognostic, COPD characterization, Cellular Popular Data
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
- CPD (Cellular Popular Data): morphological parameters measured in the blood count cells (neutrophils, lymphocytes, eosinophils and platelets).
- To define clinical status:
- Evaluation of dyspnea: mMRC (Modified Medical Research Council) scale Dyspnea only with strenuous exercise: 0 Dyspnea when hurrying or walking up a slight hill: 1 Walks slower than people of the same age because of dyspnea or has to stop for breath when walking at own pace: 2 Stops for breath after walking 100 yards (91 m) or after a few minutes: 3 Too dyspneic to leave house or breathless when dressing: 4
- Functional respiratory examination (flow-volume curve, lung volumes, diffusing capacity of the lungs for carbon monoxide (DLCO).
- Exercise capacity (6 minute walking test)
- Inflammation markers (C reactive protein, TNF-alpha, IL-6 (Interleukin 6), IL-1 (Interleukin 1), IL-8 (Interleukin 8), IGF-I and adiponectin).
- Sputum culture.
Measured: 3 years
Establish new phenotypes of COPD
- CPD (Cellular Popular Data): morphological parameters measured in the blood count cells (neutrophils, lymphocytes, eosinophils and platelets).
- Clinical status is described in previous outcome.
Measured: 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
- CPD (Cellular Popular Data): morphological parameters measured in the blood count cells (neutrophils, lymphocytes, eosinophils and platelets).
- Clinical status is described in previous outcome.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Jan 2018
- Primary completion1 Jan 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hospital Galdakao-Usansolo
- Sponsor type
- Other government
- Collaborators
- Osakidetza
- Responsible party
- Principal investigator, Dr. Cristobal Esteban, Hospital Galdakao-Usansolo
- Investigators
- Cristobal Esteban, MD, Principal investigator, Osakidetza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923360
- Sponsor's protocol ID
- G95756334
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mathers CD, Loncar D. Updated projections of global mortality and burden of disease, 2002-2030.World Health Organization, http//www.who.int/healthinfo/statistics/bodprojectionspaper.pdf.
World Health Organization. Chronic Obstructive Pulmonary Disease (COPD). Avalaible from: http:// www.who.int/respiratory/copd/en/index.html
Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.
PubMed 12324669Esteban C, Quintana JM, Moraza J, Aburto M, Egurrola M, Espana PP, Perez-Izquierdo J, Aguirre U, Aizpiri S, Capelastegui A. Impact of hospitalisations for exacerbations of COPD on health-related quality of life. Respir Med. 2009 Aug;103(8):1201-8. doi: 10.1016/j.rmed.2009.02.002. Epub 2009 Mar 9.
PubMed 19272762Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005 Nov;60(11):925-31. doi: 10.1136/thx.2005.040527. Epub 2005 Jul 29.
PubMed 16055622Yoon HI, Li Y, Man SFP, Tashkin D, Wise RA, Connett JE, Anthonisen NA, Churg A, Wright JL, Sin DD. The complex relationship of serum adiponectin to COPD outcomes COPD and adiponectin. Chest. 2012 Oct;142(4):893-899. doi: 10.1378/chest.11-2173.
PubMed 22207678Romundstad S, Naustdal T, Romundstad PR, Sorger H, Langhammer A. COPD and microalbuminuria: a 12-year follow-up study. Eur Respir J. 2014 Apr;43(4):1042-50. doi: 10.1183/09031936.00160213. Epub 2014 Jan 16.
PubMed 24435009Zemans RL, Jacobson S, Keene J, Kechris K, Miller BE, Tal-Singer R, Bowler RP. Multiple biomarkers predict disease severity, progression and mortality in COPD. Respir Res. 2017 Jun 13;18(1):117. doi: 10.1186/s12931-017-0597-7.
PubMed 28610627Garcia-Rivero JL, Esquinas C, Barrecheguren M, Bonnin-Vilaplana M, Garcia-Sidro P, Herrejon A, Martinez-Rivera C, Malo de Molina R, Marcos PJ, Mayoralas S, Naval E, Ros JA, Valle M, Miravitlles M. Risk Factors of Poor Outcomes after Admission for a COPD Exacerbation: Multivariate Logistic Predictive Models. COPD. 2017 Apr;14(2):164-169. doi: 10.1080/15412555.2016.1260538. Epub 2016 Dec 16.
PubMed 27983876Bafadhel M, McKenna S, Terry S, Mistry V, Reid C, Haldar P, McCormick M, Haldar K, Kebadze T, Duvoix A, Lindblad K, Patel H, Rugman P, Dodson P, Jenkins M, Saunders M, Newbold P, Green RH, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011 Sep 15;184(6):662-71. doi: 10.1164/rccm.201104-0597OC.
PubMed 21680942Arostegui I, Esteban C, Garcia-Gutierrez S, Bare M, Fernandez-de-Larrea N, Briones E, Quintana JM; IRYSS-COPD Group. Subtypes of patients experiencing exacerbations of COPD and associations with outcomes. PLoS One. 2014 Jun 3;9(6):e98580. doi: 10.1371/journal.pone.0098580. eCollection 2014.
PubMed 24892936Linssen J, Aderhold S, Nierhaus A, Frings D, Kaltschmidt C, Zanker K. Automation and validation of a rapid method to assess neutrophil and monocyte activation by routine fluorescence flow cytometry in vitro. Cytometry B Clin Cytom. 2008 Sep;74(5):295-309. doi: 10.1002/cyto.b.20422.
PubMed 18431775Cornet E, Boubaya M, Troussard X. Contribution of the new XN-1000 parameters NEUT-RI and NEUT-WY for managing patients with immature granulocytes. Int J Lab Hematol. 2015 Oct;37(5):e123-6. doi: 10.1111/ijlh.12372. Epub 2015 Apr 28. No abstract available.
PubMed 25923650Buoro S, Seghezzi M, Vavassori M, Dominoni P, Apassiti Esposito S, Manenti B, Mecca T, Marchesi G, Castellucci E, Azzara G, Ottomano C, Lippi G. Clinical significance of cell population data (CPD) on Sysmex XN-9000 in septic patients with our without liver impairment. Ann Transl Med. 2016 Nov;4(21):418. doi: 10.21037/atm.2016.10.73.
PubMed 27942509Urrechaga E, Boveda O, Aguirre U. Role of leucocytes cell population data in the early detection of sepsis. J Clin Pathol. 2018 Mar;71(3):259-266. doi: 10.1136/jclinpath-2017-204524. Epub 2017 Aug 18.
PubMed 28821583
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological Parameters of Blood Cell's Activation in Characterization and Prognosis in a COPD Patients Cohort
- ClinicalTrials.gov ID
- NCT04923360
- Acronym / sponsor ID
- G95756334
- Conditions
- COPD
- Keywords
- COPD prognostic, COPD characterization, Cellular Popular Data
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Hospital Galdakao-UsansoloOther government
- Collaborators
- Osakidetza
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- 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.
- Establish different phenotypes of COPD (in stable phase) according to the CPD values.
- 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.
The study will include 500 patients with different levels of COPD in the OSI-Barrualde and OSI-Bilbao. Several clinical measurements will be carried out for their characterization. CPD measurements will be made both in clinical stability phase or during exacerbations.
Detailed description
One of the most analyzed outcomes in COPD (Chronic Pulmonary Obstructive Disease) are the exacerbations, specially the severe ones. There are two challenges in relation to severe exacerbations: one related to the high use of sanitary resources and costs; and the second one, related to the worsening of the pulmonary function and the quality of life.
Nowadays in the Spanish COPD guideline called GESEPOC (Guía Española de la Enfermedad Pulmonar Obstructiva Crónica), there is a COPD "exacerbator" phenotype. However, there are some limitations round the COPD exacerbation, like its definition or its predictors. In other words, there are no indicators that can help the investigators to define more precisely an exacerbation or the COPD exacerbator profile.
COPD is a chronic disease with low intensity, systemic and chronic inflammation. The matter is that it is not established which indicators the investigators have to use to determinate it. There are some indicators like C reactive protein, TNF-alpha, IL-6 (Interleukin 6), microalbumins and adiponectin; and there are also prognostic scores based on them. However, they cannot help the investigators to establish COPD phenotypes of patients that can suffer an exacerbation. The investigators neither have indicators in stable phase that say them the risk of an exacerbation. Moreover, it is said that there are different types of exacerbations and even it has been established indicators of these exacerbation phenotypes. However, nowadays it cannot be translated into daily clinical practice. If investigators would be able to do it, they could advance in the knowledge of the exacerbations and they could establish precision treatments.
The blood count is one of the most required laboratory test in clinical practice. It is cost-effective because of its low price and the huge quantity of information it brings. After adapting the flow cytometry in hematologic modern analyzers, a more detailed study of cells can be done. Moreover, morphological changes can be detected in response to different stimulus, like infections or the ones that are caused by inflammatory reactions.
In this project, CPD ("Cellular Popular Data") is added to the basis blood count. They are parameters that are under investigation nowadays. The CPD of the XN analyzers (Sysmex Corporation, Kobe, Japan) give quantitative information about morphological and functional characteristics of leukocytes: their volume, the quantity of nucleic acid they contain and the structure of the cytoplasm. The CPD are numeric data that represent the morphology of the neutrophils, lymphocytes, monocytes and eosinophils, and they classify them by their volume, form, granularity and nucleic acid content. The same technology allows to the analyzer to classify the platelets by their morphology, what is related to its thrombogenic activity.
The composition of the membrane of the activated cells is different from the one of cells that are at rest, because of the expression of the receptors and the surface signaling molecules, in response to the activation. This membrane is more sensitive to the reagents of the analyzer, and more quantity of fluorescent colorant can enter in the activated cell and link to the cytoplasmic organelles and nucleic acids. The optic signals are different, what allows to distinguish morphological changes, and they are directly related to the cell functionality.
The activated neutrophils and monocytes have more "deformability", mobility and more capacity to adhesion, granulation and liberation of cytokines.
CPD values reflect morphological and functional transformation of these activated cells, and they give us very important information of the state of the cell and the state of the patient at the moment the sample is taken.
In addition, CPD support the differentiation between viral and bacterial infections or between acute and chronic infections, but also they say if there is an inflammatory condition without infection, with better diagnostic performance than conventional parameters, like total leukocytes, neutrophiles percentage and C reactive protein, that traditionally are used like acute infection markers.
Currently available literature speaks about the utility of CPD in the diagnosis, but there is no data about their possible prognostic value.
Respect from blood cells, previous COPD studies showed the relation between neutrophils/lymphocytes and platelets/lymphocytes as prognostic factors during severe exacerbations in COPD. Nowadays, it is emphasized the importance of eosinophils in COPD like predictor of exacerbation, like exacerbation severity marker and like response marker to the treatment in stable and in the exacerbation phase. It is thought that in this study the prognostic capacity of these new approaches can be better, becauseit is included the grade of activation of these cells like key parameter. This is a novel approach in the COPD field.
On the other hand, other inflammatory biomarkers (TNF-alpha, IL-6…) are expensive and less accessible in the daily clinical practice, while the evaluation of these new biomarkers of leukocytes are cheaper and more available in routine clinical practice by the blood count.
These new biomarkers could help the investigators confirming the inflammatory response and recognizing patients that could exacerbate. They also could determine the kind of their exacerbation and their prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Establish CPD (Cellular Popular Data) values for each phenotype of COPD.
Time frame: 3 years
* 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 secondary outcomes
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.
Time frame: 3 years
Establish new phenotypes of COPD
Time frame: 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
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- BackgroundMathers CD, Loncar D. Updated projections of global mortality and burden of disease, 2002-2030.World Health Organization, http//www.who.int/healthinfo/statistics/bodprojectionspaper.pdf.
- BackgroundWorld Health Organization. Chronic Obstructive Pulmonary Disease (COPD). Avalaible from: http:// www.who.int/respiratory/copd/en/index.html
- Background: PubMed 12324669Donaldson GC, Seemungal TA, Bhowmik A, Wedzicha JA. Relationship between exacerbation frequency and lung function decline in chronic obstructive pulmonary disease. Thorax. 2002 Oct;57(10):847-52. doi: 10.1136/thorax.57.10.847.
- Background: PubMed 19272762Esteban C, Quintana JM, Moraza J, Aburto M, Egurrola M, Espana PP, Perez-Izquierdo J, Aguirre U, Aizpiri S, Capelastegui A. Impact of hospitalisations for exacerbations of COPD on health-related quality of life. Respir Med. 2009 Aug;103(8):1201-8. doi: 10.1016/j.rmed.2009.02.002. Epub 2009 Mar 9.
- Background: PubMed 16055622Soler-Cataluna JJ, Martinez-Garcia MA, Roman Sanchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005 Nov;60(11):925-31. doi: 10.1136/thx.2005.040527. Epub 2005 Jul 29.
- Background: PubMed 22207678Yoon HI, Li Y, Man SFP, Tashkin D, Wise RA, Connett JE, Anthonisen NA, Churg A, Wright JL, Sin DD. The complex relationship of serum adiponectin to COPD outcomes COPD and adiponectin. Chest. 2012 Oct;142(4):893-899. doi: 10.1378/chest.11-2173.
- Background: PubMed 24435009Romundstad S, Naustdal T, Romundstad PR, Sorger H, Langhammer A. COPD and microalbuminuria: a 12-year follow-up study. Eur Respir J. 2014 Apr;43(4):1042-50. doi: 10.1183/09031936.00160213. Epub 2014 Jan 16.
- Background: PubMed 28610627Zemans RL, Jacobson S, Keene J, Kechris K, Miller BE, Tal-Singer R, Bowler RP. Multiple biomarkers predict disease severity, progression and mortality in COPD. Respir Res. 2017 Jun 13;18(1):117. doi: 10.1186/s12931-017-0597-7.
- Background: PubMed 27983876Garcia-Rivero JL, Esquinas C, Barrecheguren M, Bonnin-Vilaplana M, Garcia-Sidro P, Herrejon A, Martinez-Rivera C, Malo de Molina R, Marcos PJ, Mayoralas S, Naval E, Ros JA, Valle M, Miravitlles M. Risk Factors of Poor Outcomes after Admission for a COPD Exacerbation: Multivariate Logistic Predictive Models. COPD. 2017 Apr;14(2):164-169. doi: 10.1080/15412555.2016.1260538. Epub 2016 Dec 16.
- Background: PubMed 21680942Bafadhel M, McKenna S, Terry S, Mistry V, Reid C, Haldar P, McCormick M, Haldar K, Kebadze T, Duvoix A, Lindblad K, Patel H, Rugman P, Dodson P, Jenkins M, Saunders M, Newbold P, Green RH, Venge P, Lomas DA, Barer MR, Johnston SL, Pavord ID, Brightling CE. Acute exacerbations of chronic obstructive pulmonary disease: identification of biologic clusters and their biomarkers. Am J Respir Crit Care Med. 2011 Sep 15;184(6):662-71. doi: 10.1164/rccm.201104-0597OC.
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- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristobal Esteban, MD principal investigator
Osakidetza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Hospital Galdakao-Usansolo at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristobal Esteban, MD (+34 94 400 7002, cristobal.est@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Establish CPD (Cellular Popular Data) values for each phenotype of COPD. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04923360, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.