Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD
Airway Inflammatory Profile and Clinical Presentation of COPD: A Comparison Between Never Smokers and Smokers
Visão geral do estudo
Status
Condições
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Subjects with COPD, according to GOLD criteria (smokers and never smokers). Moreover, inhaled short-acting β2-agonists were stopped at least 8h before the test and inhaled long-acting β2-agonist were stopped at least 48h before the test.
- Healthy control subjects : never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms.
Exclusion Criteria:
- COPD patients were excluded from the study if they had an exacerbation, a respiratory tract infection or if they used a systemic form of corticosteroid preparation (oral or intravenous injection therapy) or antibiotics within the two months prior to the study entry. Patients with other respiratory disorder like pneumonia, pulmonary emboli, congestive heart failure, lung cancer or tuberculosis were also excluded.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Controle de caso
- Perspectivas de Tempo: Retrospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Healthy subjects
Healthy non-smoking subjects were never smokers with normal spirometry and did not have a history of lung disease or chronic respiratory symptoms. Information about respiratory symptoms and comorbidities were collected. Healthy subjects underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). |
Induced sputum was collected and analysed in the three arms (Healthy subjects, Never smokers with COPD and smokers with COPD) The volume of the sputum sample, was treated with an equal volume of 0.1% dithiothreitol. The samples were then vortexed and placed in a shaking water bath at 37°C for 15 min to ensure complete homogeneisation. The suspensions were centrifuged at 400× g and the sputum supernatant stored at -80°C until cytokines analysis. The cell pellet was resuspended in 0.5% bovine serum albumin in phosphate buffered saline and cytospin were made by putting 100 µL of the cell suspension in the funnels. Slides for differential cell counts were stained with May-Grünwald Giemsa. All the subjects underwent pulmonary function tests (Healthy subjects, Never smokers with COPD and smokers with COPD). Pulmonary function parameters were measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the ATS criteria (American Thoracic Society). Reversibility test was performed 15 min after inhalation of 400 µg of Salbutamol (Ventolin, GlaxoSmithKline, Middlesex, UK). All spirometry data were graded for quality and only tests that met high quality scores were used for the final analysis.
Outros nomes:
IL-8 and TNF-α were measured in the sputum supernatant of all the subjects (Healthy subjects, Never smokers with COPD and smokers with COPD). Commercially available kits were used to detect IL-8 (Human IL-8 Immuno-Biological Laboratories ELISA Kit) and TNF-α (Human TNF-alpha Sigma-Aldrich ELISA Kit) concentrations in the sputum supernatants. The absorbance was measured at 450 nm. The lower limits detection were 2 pg/mL for IL-8 and 5 pg/mL for TNF-α. The intra assay coefficients of variability were 8.7% for IL-8 and 7.7% for TNF- α.
Outros nomes:
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COPD Never smokers
Never smokers referred to subjects who had never smoked Airflow limitation in COPD was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio <70% and FEV1 reversibility of <12% and 200 mL from baseline values after inhalation of 400 µg of Salbutamol. Information about respiratory symptoms and comorbidities were collected. Never smoking subjects with COPD underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). |
Induced sputum was collected and analysed in the three arms (Healthy subjects, Never smokers with COPD and smokers with COPD) The volume of the sputum sample, was treated with an equal volume of 0.1% dithiothreitol. The samples were then vortexed and placed in a shaking water bath at 37°C for 15 min to ensure complete homogeneisation. The suspensions were centrifuged at 400× g and the sputum supernatant stored at -80°C until cytokines analysis. The cell pellet was resuspended in 0.5% bovine serum albumin in phosphate buffered saline and cytospin were made by putting 100 µL of the cell suspension in the funnels. Slides for differential cell counts were stained with May-Grünwald Giemsa. All the subjects underwent pulmonary function tests (Healthy subjects, Never smokers with COPD and smokers with COPD). Pulmonary function parameters were measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the ATS criteria (American Thoracic Society). Reversibility test was performed 15 min after inhalation of 400 µg of Salbutamol (Ventolin, GlaxoSmithKline, Middlesex, UK). All spirometry data were graded for quality and only tests that met high quality scores were used for the final analysis.
Outros nomes:
IL-8 and TNF-α were measured in the sputum supernatant of all the subjects (Healthy subjects, Never smokers with COPD and smokers with COPD). Commercially available kits were used to detect IL-8 (Human IL-8 Immuno-Biological Laboratories ELISA Kit) and TNF-α (Human TNF-alpha Sigma-Aldrich ELISA Kit) concentrations in the sputum supernatants. The absorbance was measured at 450 nm. The lower limits detection were 2 pg/mL for IL-8 and 5 pg/mL for TNF-α. The intra assay coefficients of variability were 8.7% for IL-8 and 7.7% for TNF- α.
Outros nomes:
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COPD Smokers
Smokers were defined as persons who had smoked > 20 packs of cigarettes in a lifetime and who continue smoking every day. Airflow limitation in COPD was defined as a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio <70% and FEV1 reversibility of <12% and 200 mL from baseline values after inhalation of 400 µg of Salbutamol. Information about respiratory symptoms and comorbidities were collected. Smoking subjects with COPD underwent pulmonary function tests (Spirometry). Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 and tumor necrosis factor-alpha). |
Induced sputum was collected and analysed in the three arms (Healthy subjects, Never smokers with COPD and smokers with COPD) The volume of the sputum sample, was treated with an equal volume of 0.1% dithiothreitol. The samples were then vortexed and placed in a shaking water bath at 37°C for 15 min to ensure complete homogeneisation. The suspensions were centrifuged at 400× g and the sputum supernatant stored at -80°C until cytokines analysis. The cell pellet was resuspended in 0.5% bovine serum albumin in phosphate buffered saline and cytospin were made by putting 100 µL of the cell suspension in the funnels. Slides for differential cell counts were stained with May-Grünwald Giemsa. All the subjects underwent pulmonary function tests (Healthy subjects, Never smokers with COPD and smokers with COPD). Pulmonary function parameters were measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the ATS criteria (American Thoracic Society). Reversibility test was performed 15 min after inhalation of 400 µg of Salbutamol (Ventolin, GlaxoSmithKline, Middlesex, UK). All spirometry data were graded for quality and only tests that met high quality scores were used for the final analysis.
Outros nomes:
IL-8 and TNF-α were measured in the sputum supernatant of all the subjects (Healthy subjects, Never smokers with COPD and smokers with COPD). Commercially available kits were used to detect IL-8 (Human IL-8 Immuno-Biological Laboratories ELISA Kit) and TNF-α (Human TNF-alpha Sigma-Aldrich ELISA Kit) concentrations in the sputum supernatants. The absorbance was measured at 450 nm. The lower limits detection were 2 pg/mL for IL-8 and 5 pg/mL for TNF-α. The intra assay coefficients of variability were 8.7% for IL-8 and 7.7% for TNF- α.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Weight measurement
Prazo: 6 months
|
Weight was measured in kilograms for all the participants.
|
6 months
|
|
Height measurement
Prazo: 6 months
|
Height was measured in meters for all the participants.
|
6 months
|
|
Forced vital capacity (FVC)
Prazo: 6 months
|
FVC was measured using a portable spirometer (Easy One ndd.
Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
|
6 months
|
|
Forced expiratory volume in one second (FEV1)
Prazo: 6 months
|
FEV1 was measured using a portable spirometer (Easy One ndd.
Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
|
6 months
|
|
Sputum induction and collection
Prazo: 6 months
|
Sputum induction was conducted by inhalation of nebulised sterile hypertonic saline solution followed by coughing and expectoration of airway secretions.
For nebulisation, an ultrasound nebulizer was used for 5-20 min to provide an adequate amount of sample.
The subject is asked to cough and expectorate at 5 min intervals.
|
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
BMI determination
Prazo: 6 months
|
Weight and height values were combined to report BMI in kg/m2
|
6 months
|
|
Tiffeneau ratio (FEV1/FVC)
Prazo: 6 months
|
The calculation of FEV1/FVC allows the identification of obstructive ventilatory defect.
A FEV1/FVC < 70 % where FEV1 is reduced more than FVC signifies an obstructive defect.
|
6 months
|
|
Sputum cell counts
Prazo: 1 month
|
Four hundred non-squamous cells were counted by two technicians and the mean of the two scores was expressed as percentage of the total cell count.
Sputum samples containing >20% of squamous cells and/or with cell viability <70% were excluded from analysis.
|
1 month
|
|
Sputum supernatant analyses
Prazo: 3 months
|
IL-8 and TNF-α sputum supernatant concentrations were measured in the sputum supernatant of the three studied groups using ELISA test.
|
3 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Zouhair Tabka, MD PhD, Faculty of medicine of Sousse
- Investigador principal: Amina Mrizak, MSc, Faculty of medicine of Sousse
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- COPDNS
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Relatório de Estudo Clínico (CSR)
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