Pulmonary Disease, Chronic ObstructiveNCT02732444
Erythrocytes Membrane Stability in COPD Patients in Long-Term Home Oxygen Therapy
An observational study of Pulmonary Disease, Chronic Obstructive, run by Federal University of Uberlandia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- How many people
- 200 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2016to Nov 2017
- How long will I take part?
- 2 Days
- 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 40 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital of clinics of the federal university of uberlândia
Uberlândia, Minas Gerais
About this study
Official title: Erythrocytes Membrane Stability in Chronic Obstructive Pulmonary Disease Patients in Long-Term Home Oxygen Therapy
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.
Read the detailed description
COPD is a major cause of illness and death worldwide, representing a significant economic and social cost. In the household, it causes concern, limited social life and leisure; commits the budget and shortens life. In the professional field, reduces productivity, anticipates the retirement and results in pension payments and benefits. In the area of health system, motivates repeated calls in emergency rooms, outpatient clinics and is a frequent cause of hospitalizations, which causes high costs for government and society. Most cases can be attributed to smoke.
COPD is often developed in middle-aged smokers with long time exposure which have a variety of other diseases related to smoking or aging. COPD itself has also significant extra-pulmonary effects (systemic) that lead to comorbid conditions. Nutritional abnormalities, weight loss and skeletal muscle dysfunction are well-recognized extrapulmonary effects of COPD and patients are at high risk for myocardial infarction, osteoporosis, respiratory infection, bone fractures, depression, sleep disorders, anemia and glaucoma.
Thus, this study aims to investigate the erythrocyte membranes stability in patients with COPD compared to healthy individuals, since the loss or damage of the red blood cells may be related to worsening gas exchange of patients and caused, for example, by increased oxidative stress observed in the disease mechanism of COPD patients, especially those with advanced lung disease.
Cross-sectional, observational study, which will be compared COPD patients with Advanced Lung disease using Long-Term Home Oxygen Therapy to healthy subjects to evaluate the presence of difference in membrane stability in the red blood cells as well as differences in pulmonary function tests, physical tests, laboratory analysis and presence of oxidative stress, as well as their quality of life.
The results obtained after analysis of erythrocyte membranes stability, as well as oxidative stress and functional and laboratory tests will be correlated, both in patients with COPD Long-Term Home Oxygen Therapy as the control group in order to establish relationships between variables and also compare between groups to determine the differences among them.
- 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)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (8)
Blood Sample Collection by venipuncture into test tubes (Vacutainer) containing specific anticoagulants for each dose
The analysis of the following parameters: hematological evaluation (complete blood count), serum levels of folic acid, cobalamin (vitamin B12), homocysteine, lipid profile, lactate dehydrogenase, serum iron, ferritin, transferrin capacity index, uric acid, glucose, albumin, reticulocytes, C-reactive protein (CRP), total bilirubin (TB), direct bilirubin (DB), indirect bilirubin (IB) and glycated hemoglobin (HbA1c).
Measured: 1 day
The blood gases analysis will be performed by Radiometer Copenhagen ABL 330TM device
Will be obtained: potential hydrogen (pH); arterial oxygen tension (PaO2), arterial carbon dioxide tension (PaCO2); and arterial oxyhemoglobin saturation (SaO2). The location and the puncture technique, sample handling and other technical considerations will be made according to the recommendation of specific guidelines of the Brazilian Thoracic Society.
Measured: 1 day
Modified Medical Research Council (MMRC) Dyspnea Scale - Quality of Life Questionnaires
British Medical Research Council developed this scale in order to predict future risk of mortality. The grades vary from 0 to 4, considering 0 better clinical condition and 4 worse health state.
Measured: 1 day
COPD Assessment Test (CAT) - Quality of Life Questionnaires
The CAT consists of eight questions assessing cough, sputum, chest tightness, dyspnea, limitations in home activities, confidence in leaving home, sleep and energy. For each item, the patient chooses only one answer option, whose score ranges from zero to five. At the end of the test, the sum of the scores results in clinical impact of COPD, according to the stratification score of development study and validation of the CAT. The results vary according to the range of the scores, ranked as follows in relation to the clinical impact: 6-10 points, light; 11-20, moderate; 21-30, severe; and 31-40, very serious.
Measured: 1 day
Clinical COPD Questionnaire (CCQ) - Quality of Life Questionnaires
The CCQ is a self-administered questionnaire used routinely for clinical evaluation of COPD patients, but was also accepted as simple and a useful tool to be used in clinical trials evaluating response treatments and interventions. It consists of 10 items that must be answered based on the last seven days of the patient, and the results indicates their clinical condition based on an intensity scale in which zero represents the minimum possible limitation or absence of breathlessness, and six maximum limitation possible. The CCQ has three domains: symptoms, functional status and mental state.
Measured: 1 day
Medical Outcome Study 36-item Short-Form Health Survey (SF-36) - Quality of Life Questionnaires
The SF-36 is a generic tool often used as a measure of health-related quality of life, easy to administer and understand, is composed of 36 items covering eight domains: physical functioning, role limitations due to physical health, pain, general health perception, vitality, social functioning, role limitations due to emotional problems and mental health. It presents a score of 0 (zero) to 100, where zero corresponds to the worst general state of health and 100 corresponds to the best state of health.
Measured: 1 day
St. George's Respiratory Questionnaire (SGRQ) - Quality of Life Questionnaires
The SGRQ is a 50-item questionnaire developed to measure health status (quality of life) in patients with diseases of airways obstruction. It is self-administered and consists of three domains: symptoms, activity and impact of disease. Each domain has a maximum possible score and the total is expressed as a percentage of that maximum, where values above 10% reflects changes on quality of life. A minimum change in score of 4 units was established as clinically relevant after patient and clinician testing.
Measured: 1 day
Airways questionnaire 20 (Aq-20) - Quality of Life Questionnaires
AQ20 is a specific questionnaire for obstructive respiratory diseases, consisting of only 20 questions, derived from a longer questionnaire: Asthma Quality of Life Questionnaire (AQLQ). On its validation, it was compared to two other more complexes questionnaires (SGRQ and AQLQ) and showed good correlation with these instruments and clinical presentation of the patient. It is self-administered and its great advantage is the short time required to answer it, only 4 minutes, and simplified answers (yes, no or not applicable).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionAug 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flaviana Ferreira Gomes, Federal University of Uberlandia
- Investigators
- Flaviana Gomes, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732444
- Sponsor's protocol ID
- FUUberlandia 01/2016
- Status last verified
- Jan 2018
- First submitted
- 10 Mar 2016
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aki H, Yamamoto M. Drug binding to human erythrocytes in the process of ionic drug-induced hemolysis. Flow microcalorimetric approaches. Biochem Pharmacol. 1991 Jan 1;41(1):133-8. doi: 10.1016/0006-2952(91)90021-v.
PubMed 1986737Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
PubMed 7154893Chasis JA, Mohandas N. Erythrocyte membrane deformability and stability: two distinct membrane properties that are independently regulated by skeletal protein associations. J Cell Biol. 1986 Aug;103(2):343-50. doi: 10.1083/jcb.103.2.343.
PubMed 3733870Cooper RA. Abnormalities of cell-membrane fluidity in the pathogenesis of disease. N Engl J Med. 1977 Aug 18;297(7):371-7. doi: 10.1056/NEJM197708182970707. No abstract available.
PubMed 327326Cunha CC, Arvelos LR, Costa JO, Penha-Silva N. Effects of glycerol on the thermal dependence of the stability of human erythrocytes. J Bioenerg Biomembr. 2007 Aug;39(4):341-7. doi: 10.1007/s10863-007-9092-z. Epub 2007 Oct 5.
PubMed 17917799Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.
PubMed 11089981McNeil 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.
PubMed 9105031Montuschi 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.
PubMed 10988150Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002 May;121(5):1434-40. doi: 10.1378/chest.121.5.1434.
PubMed 12006425Park 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.
PubMed 19144046Penha-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.
PubMed 17681589Singer 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.
PubMed 4333397Office 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/
PubMed 20669512
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythrocytes Membrane Stability in Chronic Obstructive Pulmonary Disease Patients in Long-Term Home Oxygen Therapy
- ClinicalTrials.gov ID
- NCT02732444
- Acronym / sponsor ID
- FUUberlandia 01/2016
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 8 Apr 2016 (estimated)
- 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.
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.
Detailed description
COPD is a major cause of illness and death worldwide, representing a significant economic and social cost. In the household, it causes concern, limited social life and leisure; commits the budget and shortens life. In the professional field, reduces productivity, anticipates the retirement and results in pension payments and benefits. In the area of health system, motivates repeated calls in emergency rooms, outpatient clinics and is a frequent cause of hospitalizations, which causes high costs for government and society. Most cases can be attributed to smoke.
COPD is often developed in middle-aged smokers with long time exposure which have a variety of other diseases related to smoking or aging. COPD itself has also significant extra-pulmonary effects (systemic) that lead to comorbid conditions. Nutritional abnormalities, weight loss and skeletal muscle dysfunction are well-recognized extrapulmonary effects of COPD and patients are at high risk for myocardial infarction, osteoporosis, respiratory infection, bone fractures, depression, sleep disorders, anemia and glaucoma.
Thus, this study aims to investigate the erythrocyte membranes stability in patients with COPD compared to healthy individuals, since the loss or damage of the red blood cells may be related to worsening gas exchange of patients and caused, for example, by increased oxidative stress observed in the disease mechanism of COPD patients, especially those with advanced lung disease.
Cross-sectional, observational study, which will be compared COPD patients with Advanced Lung disease using Long-Term Home Oxygen Therapy to healthy subjects to evaluate the presence of difference in membrane stability in the red blood cells as well as differences in pulmonary function tests, physical tests, laboratory analysis and presence of oxidative stress, as well as their quality of life.
The results obtained after analysis of erythrocyte membranes stability, as well as oxidative stress and functional and laboratory tests will be correlated, both in patients with COPD Long-Term Home Oxygen Therapy as the control group in order to establish relationships between variables and also compare between groups to determine the differences among them.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (13 listed)
- Control Group
- COPD Group in LTOT
Key exclusion criteria (3 listed)
- 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
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
Erythrocyte Osmotic Fragility Test (FSO)
Time frame: 1 day
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.
8 secondary outcomes
Blood Sample Collection by venipuncture into test tubes (Vacutainer) containing specific anticoagulants for each dose
Time frame: 1 day
The blood gases analysis will be performed by Radiometer Copenhagen ABL 330TM device
Time frame: 1 day
Modified Medical Research Council (MMRC) Dyspnea Scale - Quality of Life Questionnaires
Time frame: 1 day
COPD Assessment Test (CAT) - Quality of Life Questionnaires
Time frame: 1 day
Clinical COPD Questionnaire (CCQ) - Quality of Life Questionnaires
Time frame: 1 day
Medical Outcome Study 36-item Short-Form Health Survey (SF-36) - Quality of Life Questionnaires
Time frame: 1 day
St. George's Respiratory Questionnaire (SGRQ) - Quality of Life Questionnaires
Time frame: 1 day
Airways questionnaire 20 (Aq-20) - Quality of Life Questionnaires
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- Background: PubMed 1986737Aki H, Yamamoto M. Drug binding to human erythrocytes in the process of ionic drug-induced hemolysis. Flow microcalorimetric approaches. Biochem Pharmacol. 1991 Jan 1;41(1):133-8. doi: 10.1016/0006-2952(91)90021-v.
- Background: PubMed 7154893Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.
- Background: PubMed 3733870Chasis JA, Mohandas N. Erythrocyte membrane deformability and stability: two distinct membrane properties that are independently regulated by skeletal protein associations. J Cell Biol. 1986 Aug;103(2):343-50. doi: 10.1083/jcb.103.2.343.
- Background: PubMed 327326Cooper RA. Abnormalities of cell-membrane fluidity in the pathogenesis of disease. N Engl J Med. 1977 Aug 18;297(7):371-7. doi: 10.1056/NEJM197708182970707. No abstract available.
- Background: PubMed 17917799Cunha CC, Arvelos LR, Costa JO, Penha-Silva N. Effects of glycerol on the thermal dependence of the stability of human erythrocytes. J Bioenerg Biomembr. 2007 Aug;39(4):341-7. doi: 10.1007/s10863-007-9092-z. Epub 2007 Oct 5.
- Background: PubMed 11089981Finkel T, Holbrook NJ. Oxidants, oxidative stress and the biology of ageing. Nature. 2000 Nov 9;408(6809):239-47. doi: 10.1038/35041687.
- Background: PubMed 9105031McNeil 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.
- Background: PubMed 10988150Montuschi 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.
- Background: PubMed 12006425Nishimura K, Izumi T, Tsukino M, Oga T. Dyspnea is a better predictor of 5-year survival than airway obstruction in patients with COPD. Chest. 2002 May;121(5):1434-40. doi: 10.1378/chest.121.5.1434.
- Background: PubMed 19144046Park 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.
- Background: PubMed 17681589Penha-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.
- Background: PubMed 4333397Singer 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.
- 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.
Flaviana Gomes principal investigator
Federal University of Uberlandia
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 Pulmonary Disease, Chronic Obstructive, run by Federal University of Uberlandia at 1 site in Brazil.
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 13 inclusion and 3 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: finished, as of the sponsor's last update on 17 Jan 2018. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocyte Osmotic Fragility Test (FSO) (time frame: 1 day). 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 NCT02732444, which also lists 13 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 17 Jan 2018.