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临床试验/NCT03274791
NCT03274791已完成不适用

Airway Inflammatory Profile and Clinical Presentation of COPD: A Comparison Between Never Smokers and Smokers

Ministry of Scientific Research, Tunisia0 个研究点目标入组 68 人开始时间: 2013年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
68
主要终点
Sputum induction and collection

研究概览

简要总结

The aim of this study was to investigate the airway inflammatory profile and the clinical presentation of chronic obstructive pulmonary disease (COPD) in never smokers compared to smokers with COPD.

详细描述

40 COPD patients (21 smokers and 19 never smokers) and 28 healthy never smokers were included in the present study. Information about respiratory symptoms and comorbidities were collected. Subjects underwent pulmonary function tests and COPD was defined according to Global Initiative for Chronic Obstructive lung Disease spirometric criteria. Induced sputum was collected to determine total and differential inflammatory cells counts as well as inflammatory mediators (Interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α)). The Mann-Whitney U and the χ2 tests were used for results comparisons. Correlations between symptoms, spirometric parameters, cytokines levels, inflammatory cells and risk factors of COPD were examined with Spearman's rank correlation test.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Sputum induction and collection

时间窗: 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.

Forced expiratory volume in one second (FEV1)

时间窗: 6 months

FEV1 was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.

Weight measurement

时间窗: 6 months

Weight was measured in kilograms for all the participants.

Forced vital capacity (FVC)

时间窗: 6 months

FVC was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.

Height measurement

时间窗: 6 months

Height was measured in meters for all the participants.

次要结局

  • Tiffeneau ratio (FEV1/FVC)(6 months)
  • BMI determination(6 months)
  • Sputum supernatant analyses(3 months)
  • Sputum cell counts(1 month)

研究者

发起方
Ministry of Scientific Research, Tunisia
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Myriam Denguezli

Assistant Professor

Ministry of Scientific Research, Tunisia

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