Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD
- Conditions
- COPDAirway ObstructionInflammation
- Registration Number
- NCT03274791
- Lead Sponsor
- Ministry of Scientific Research, Tunisia
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Sputum induction and collection 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) 6 months FEV1 was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
Weight measurement 6 months Weight was measured in kilograms for all the participants.
Forced vital capacity (FVC) 6 months FVC was measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the American Thoracic Society criteria.
Height measurement 6 months Height was measured in meters for all the participants.
- Secondary Outcome Measures
Name Time Method Tiffeneau ratio (FEV1/FVC) 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.
BMI determination 6 months Weight and height values were combined to report BMI in kg/m2
Sputum supernatant analyses 3 months IL-8 and TNF-α sputum supernatant concentrations were measured in the sputum supernatant of the three studied groups using ELISA test.
Sputum cell counts 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.