Biomarkers for Diagnosis and Treatment of COPD

NCT02633280 | Completed DMC

• 1 other identifier: COPD
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 3

Brief Summary

COPD is an inflammatory disease characterized by enhanced chronic airway and lung inflammatory responses to noxious agents (e.g. smoke, pollutants) and progressive airflow limitation. In COPD patients there is a spillover of peripheral lung inflammation into systemic circulation resulting in increased level of various inflammatory markers such as: IL-1β, IL-6, IL-8, and TNF-α. Diagnosis, now, is based on clinical evaluation and spirometry test and COPD treatment includes the use of LABA, LAMA and corticosteroids. To data no plasmatic marker able to identify the stage of COPD and the response to the treatment have been documented . The aim of this study is to evaluate in COPD patients the role of microRNA as predictive biomarker, of the disease in order to have a signature of miRs typically of COPD

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• Change of miR expression at 6 and 12 months

  Change of miR expression in COPD-groups (Groups 1 and 2 ) vs control-Group

  6 and 12 months

Secondary Outcomes (3)

• correlation between miRs expression and clinical outcome

  6 and 12 months

• correlation between miRs expression and the development of adverse drug reaction

  6 and 12 months

• correlation between miRs expression and inflammatory markers

  6 and 12 months

Study Arms (3)

COPD-Untreated (Group 1)

In this Group will be enrolled patients of both sex and older than 40-years with COPD stage GOLD 2 and 3 that did not receive COPD treatment in the last 6 months (beta 2 agonists, corticosteroids, anticholinergics).

COPD-uncontrolled (Group 2)

In this Group will be enrolled patients of both sex and older than 40-years with COPD stage GOLD 2 and 3 that receive a COPD treatment (e.g. beta 2 agonists, corticosteroids, anticholinergics) but with a post-bronchodilator FEV1\< 80% and an FEV1/FVC \< 0.7 or with 1-2 exacerbation/year

Control subjects (Group 3)

In this Group will be enrolled patients of both sex and older than 40 years; (2) will be free from lung disease as determined by a physician; (3) will have a normal spirometry (FEV1\> 85% and FEV1/FVC \> 0.7)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

An open label, parallel groups study, will be performed after it is approve by the Ethical committee and before the beginning of the study, all participants will be informed about the aim, procedures, risks and benefits of the study and they will provide a written informed consent

You may qualify if:

• COPD diagnosed according to the GOLD criteria

You may not qualify if:

• allergy to corticosteroids or to bronchodilators
• neurodegenerative diseases
• autoimmune diseases
• inability to use inhalers
• progressive serious medical conditions (such as cancer, AIDS or end-stage renal disease)
• infectious diseases

Sponsors & Collaborators

• University of Catanzaro: lead

Study Sites (3)

UCCP

Badolato, Catanzaro, 88100, Italy

Location

UCCP

Borgia, Catanzaro, 88100, Italy

Location

UCCP

Catanzaro, 88100, Italy

Location

Related Publications (7)

• Garvey C. Recent updates in chronic obstructive pulmonary disease. Postgrad Med. 2016;128(2):231-8. doi: 10.1080/00325481.2016.1118352. Epub 2015 Dec 1.

  PMID: 26560514 RESULT

• Vestbo J, Hurd SS, Agusti AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9.

  PMID: 22878278 RESULT

• Barnes PJ. Chronic obstructive pulmonary disease: effects beyond the lungs. PLoS Med. 2010 Mar 16;7(3):e1000220. doi: 10.1371/journal.pmed.1000220.

  PMID: 20305715 RESULT

• Sarioglu N, Hismiogullari AA, Bilen C, Erel F. Is the COPD assessment test (CAT) effective in demonstrating the systemic inflammation and other components in COPD? Rev Port Pneumol (2006). 2016 Jan-Feb;22(1):11-7. doi: 10.1016/j.rppnen.2015.08.007. Epub 2015 Oct 31.

  PMID: 26534740 RESULT

• Stolzenburg LR, Wachtel S, Dang H, Harris A. miR-1343 attenuates pathways of fibrosis by targeting the TGF-beta receptors. Biochem J. 2016 Feb 1;473(3):245-56. doi: 10.1042/BJ20150821. Epub 2015 Nov 5.

  PMID: 26542979 RESULT

• Watt J, Ganapathi P. COPD: Novel therapeutics and management strategies--SMi's 7th Annual Conference (October 19-20, 2015--London, UK). Drugs Today (Barc). 2015 Oct;51(10):613-7. doi: 10.1358/dot.2015.51.10.2409817.

  PMID: 26583304 RESULT

• Agusti A, Edwards LD, Rennard SI, MacNee W, Tal-Singer R, Miller BE, Vestbo J, Lomas DA, Calverley PM, Wouters E, Crim C, Yates JC, Silverman EK, Coxson HO, Bakke P, Mayer RJ, Celli B; Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) Investigators. Persistent systemic inflammation is associated with poor clinical outcomes in COPD: a novel phenotype. PLoS One. 2012;7(5):e37483. doi: 10.1371/journal.pone.0037483. Epub 2012 May 18.

  PMID: 22624038 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

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

• Luca Gallelli, MD

  University of Catanzaro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2015
• First Posted: December 17, 2015
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: October 1, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

IT (3)