Clinical trial NCT03274791: Clinical Features and Airways Inflammation in Never Smokers and Smokers With COPD
Official title: Airway Inflammatory Profile and Clinical Presentation of COPD: A Comparison Between Never Smokers and Smokers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Airway Obstruction
Inflammation
Keywords: COPD
smoking
induced sputum
clinical features
Lead sponsor: Ministry of Scientific Research, Tunisia
Sponsor class: OTHER_GOV
First posted: 2017-09-07
Enrollment: 68
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were recruited from the department of physiology and functional explorations of Sousse University Hospital. 40 subjects with COPD, according to GOLD criteria (21 current smokers and 19 never smokers) and 28 healthy control subjects participated to the study.

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.

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.

Primary outcomes:
measure: Weight measurement
timeFrame: 6 months
measure: Height measurement
timeFrame: 6 months
measure: Forced vital capacity (FVC)
timeFrame: 6 months
measure: Forced expiratory volume in one second (FEV1)
timeFrame: 6 months
measure: Sputum induction and collection
timeFrame: 6 months
Secondary outcomes:
measure: BMI determination
timeFrame: 6 months
measure: Tiffeneau ratio (FEV1/FVC)
timeFrame: 6 months
measure: Sputum cell counts
timeFrame: 1 month
measure: Sputum supernatant analyses
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine of Sousse
name: Zouhair Tabka, MD PhD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine of Sousse
name: Amina Mrizak, MSc
role: PRINCIPAL_INVESTIGATOR
References: