Erythrocytes Membrane Stability in COPD Patients in Long-Term Home Oxygen Therapy

NCT02732444 | Completed

• 1 other identifier: FUUberlandia 01/2016
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic Obstructive Pulmonary Disease (COPD) patients in Long-Term Home Oxygen Therapy (LTOT) have a reduction in airflow that is not totally reversible. This obstruction may be associated with an abnormal inflammatory response of the lungs as a result of inhalation of toxic particles, particularly to cigarette smoke. Furthermore, COPD patients also present limited symptoms to physical exercise, significant extrapulmonary effects, including weight loss, nutritional abnormalities and skeletal muscle dysfunction. Hyperinflation has been identified as a major cause of dyspnea and is currently believed to be already present in the early stages of the disease, causing limitations in physical capacity. The progressive exertional dyspnea is most associated with impairment to activities of daily living, decreased quality of life and worse prognosis. Traditionally, the severity of COPD is defined by the degree of obstruction, as measured by forced expiratory volume in one second (FEV1) after bronchodilator use (post-BD) and can be classified as mild, moderate, moderately severe and very severe disease. In the group of patients with Advanced Pulmonary Disease (APD), those with partial pressure values of oxygen (PaO2) lower or equal to 55mmHg, or arterial oxygen saturation (SaO2) lower or equal to 88% in ambient air; or those with PaO2 values between 55-60 or SaO2 lower than 90%, with evidence of pulmonary hypertension or polycythemia require LTOT, over 15 hours / day, with evidence of increased survival. The aim of this study is to evaluate the erythrocyte membranes stability in COPD and APD patients in LTOT compared to healthy subjects. It is a cross-sectional, observational study with evaluation of erythrocyte membranes stability among the groups as well as lung function, physical testing, laboratory analysis, oxidative stress and quality of life questionnaires. As red blood cells are the cells responsible for the gas exchange in the lungs and peripheral tissues, and since the patients with COPD and APD have gas exchange impairment compared to the healthy group, it is expected to find a difference in erythrocyte membranes stability and levels of oxidative stress among the groups.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Erythrocytes Membranes Stability; Oxidative Stress; Chronic Obstructive Pulmonary Disease (COPD); Advanced Pulmonary Disease (APD); Long-Term Home Oxygen Therapy (LTOT)

Outcome Measures

Primary Outcomes (1)

• Erythrocyte Osmotic Fragility Test (FSO)

  The stability of erythrocytes is an inverse function of their osmotic fragility and can be measured by erythrocyte osmotic fragility test (FSO). The test of the FSO provides four parameters for the cell stability of measurement: dX, H50, Amax and Amin. Dx parameter expresses variation in salt concentration necessary to take intact erythrocytes (Amin) to a complete lysis state (Amax), with a 100% hemolysis. Increased dX values expresses greater stability of erythrocytes. The H50 parameter is related to the salt concentration required to produce 50% hemolysis. H50 larger values expresses lower stability of erythrocytes.

  1 day

Secondary Outcomes (8)

• Blood Sample Collection by venipuncture into test tubes (Vacutainer) containing specific anticoagulants for each dose

  1 day

• The blood gases analysis will be performed by Radiometer Copenhagen ABL 330TM device

  1 day

• Modified Medical Research Council (MMRC) Dyspnea Scale - Quality of Life Questionnaires

  1 day

• COPD Assessment Test (CAT) - Quality of Life Questionnaires

  1 day

• Clinical COPD Questionnaire (CCQ) - Quality of Life Questionnaires

  1 day

Other Outcomes (5)

• Spirometry - Pulmonary Function Testing

  1 day

• Plethysmography - Pulmonary Function Testing

  1 day

• Carbon Monoxide Diffusion - Pulmonary Function Testing

  1 day

Study Arms (2)

COPD and APD patients in LTOT

• COPD and APD patients in LTOT

Healthy Control

• Patients without significant cardiorespiratory disease, matched for age and body mass index with the other group.

Eligibility Criteria

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

Study Population

Will be selected 100 participants with COPD in Home Oxygen Therapy at HC-UFU, which will be compared with the same amount of healthy individuals, selected in the General Ambulatories of the same hospital and of family health programs of the city of Uberlandia.

You may qualify if:

• Control Group
• Patients without significant cardiorespiratory disease diagnosed, matched for age and body mass index to the group of COPD patients and APD in LTOT;
• Nonsmoker;
• Age group over 40 years old;
• Male gender;
• Acceptance to participate and agreement to sign the Informed Consent Term
• COPD Group in LTOT
• Patients with COPD and APD in LTOT;
• Patients who do not have associated severe heart disease;
• Patients with no pulmonary exacerbations in the past four weeks;
• Male gender;
• Age group over 40 years old;
• Acceptance to participate and agreement to sign the Informed Consent Term

You may not qualify if:

• Patients with a disability or orthopedic disfunction that unable mobility or performance of physical tests;
• Patients using lipid-lowering drugs such as statins and fibrates;
• Patients or family / guardians who refuse to sign the Informed Consent Term

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Hospital of clinics of the federal university of uberlândia

Uberlândia, Minas Gerais, Brazil

Location

Related Publications (13)

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  PMID: 17917799 BACKGROUND

• Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.

  PMID: 11089981 BACKGROUND

• McNeil PL, Steinhardt RA. Loss, restoration, and maintenance of plasma membrane integrity. J Cell Biol. 1997 Apr 7;137(1):1-4. doi: 10.1083/jcb.137.1.1. No abstract available.

  PMID: 9105031 BACKGROUND

• Montuschi P, Collins JV, Ciabattoni G, Lazzeri N, Corradi M, Kharitonov SA, Barnes PJ. Exhaled 8-isoprostane as an in vivo biomarker of lung oxidative stress in patients with COPD and healthy smokers. Am J Respir Crit Care Med. 2000 Sep;162(3 Pt 1):1175-7. doi: 10.1164/ajrccm.162.3.2001063.

  PMID: 10988150 BACKGROUND

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  PMID: 12006425 BACKGROUND

• Park HS, Kim SR, Lee YC. Impact of oxidative stress on lung diseases. Respirology. 2009 Jan;14(1):27-38. doi: 10.1111/j.1440-1843.2008.01447.x.

  PMID: 19144046 BACKGROUND

• Penha-Silva N, Firmino CB, de Freitas Reis FG, da Costa Huss JC, de Souza TM, de Freitas MV, Netto RC. Influence of age on the stability of human erythrocyte membranes. Mech Ageing Dev. 2007 Jul-Aug;128(7-8):444-9. doi: 10.1016/j.mad.2007.06.007. Epub 2007 Jun 28.

  PMID: 17681589 BACKGROUND

• Singer SJ, Nicolson GL. The fluid mosaic model of the structure of cell membranes. Science. 1972 Feb 18;175(4023):720-31. doi: 10.1126/science.175.4023.720.

  PMID: 4333397 BACKGROUND

• Office of the Surgeon General (US); Office on Smoking and Health (US). The Health Consequences of Smoking: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK44695/

  PMID: 20669512 BACKGROUND

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

• Flaviana Gomes

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biologist

Study Record Dates

• First Submitted: March 10, 2016
• First Posted: April 8, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: November 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)