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Clinical Trials/NCT03274791
NCT03274791
Completed
Not Applicable

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

Ministry of Scientific Research, Tunisia0 sites68 target enrollmentSeptember 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
COPD
Sponsor
Ministry of Scientific Research, Tunisia
Enrollment
68
Primary Endpoint
Sputum induction and collection
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2013
End Date
January 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ministry of Scientific Research, Tunisia
Responsible Party
Principal Investigator
Principal Investigator

Myriam Denguezli

Assistant Professor

Ministry of Scientific Research, Tunisia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Sputum induction and collection

Time Frame: 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)

Time Frame: 6 months

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

Weight measurement

Time Frame: 6 months

Weight was measured in kilograms for all the participants.

Forced vital capacity (FVC)

Time Frame: 6 months

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

Height measurement

Time Frame: 6 months

Height was measured in meters for all the participants.

Secondary Outcomes

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

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