Chronic Obstructive Pulmonary Disease, Exacerbation of Disease.
Conditions
Interventions
It is a prospective observational study with patients with COPD to identify clinical and laboratory characteristics that characterize different groups that may have different morbidity and mortality o
Other
L01.280.960
E01.370.225.998.110
Sponsors
Faculdade Medicina de Botucatu
AstraZeneca do Brasil Ltda
Eligibility
Inclusion criteria
Inclusion criteria: Patients with all COPD severity will be included according to the GOLD classification in 2014. Clinically stable patients, characterized by the absence of exacerbation and regular use of medications for treatment in the last three months
Exclusion criteria
Exclusion criteria: Patients who have used systemic corticosteroids in the last three months, who have other respiratory diseases; as asthma, bronchiectasis and active tuberculosis and cancer, will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| COPD exhibits heterogeneous characteristics that can vary prognoses and respond differently to possible therapeutic interventions. The complexity of the disease causes alternative tools to be sought in order to assess the severity of the patients. Patients with COPD according to the GOLD 2017 classification will be evaluated to identify clinical and laboratory characteristics in different groups with different morbidity and mortality after one year of follow-up. Patients will be submitted to the initial evaluation composed by personal identification; Associated diseases; Charlson's index, body composition; Current medication; History of smoking (years / pack), measurement of exhaled carbon monoxide; History of exacerbations / hospitalizations. The patient will perform pre- and post bronchodilator spirometry and the six-minute walk test. The Saint George Respiratory Questionnaire (SGRQ) quality of life, dyspnea, anxiety and depression questionnaires will be applied. Blood samples will also be collected for dosages of inflammatory markers, blood gases and blood counts. Cholesterol, HDL, LDL, VLDL, triglycerides, C-reactive protein, fasting glucose, interleukin-6 and vitamin D levels will be noted. Patients will be assessed every four months to quantify the frequency of exacerbations and hospitalizations, identifying which groups of patients will be followed up in COPD exacerbation, hospitalization, and mortality outcomes.;The study was carried out at the Hospital das Clínicas of the Botucatu Medical School - FMB / UNESP and at the Federal University of Triângulo Mineiro - UFTM / Uberaba - Minas Gerais / MG, between August 2016 and October 2017. The study was approved by the research ethics committee FMB / UNESP under opinion number 1 399 669 and CAAE: 52515215.2.1001.5411 and approved on the website Brazilian Registry of Clinical Trials (REBEC) with registration RBR-5B6B6S. This is an observational study with patients with COPD to identify clinical, laboratory and ass | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected | — |
Countries
Brazil
Contacts
Public ContactJosé Zucchi
Universidade Estadual Paulista "Júlio de Mesquita Filho" UNESP
Outcome results
None listed