Study to investigate the effect of 14-day treatment with BIIL 284 BS on sputum neutrophils and specific inflammatory markers in patients with clinically well-defined moderate chronic obstructive pulmonary disease (COPD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
53
Percentage of neutrophils in the induced sputum differential cell count
Time frame: Baseline, day 14
Percentage of neutrophils in the spontaneous sputum differential cell count
Time frame: Baseline, day 14
Percentage of neutrophils in the induced sputum differential cell count
Time frame: Baseline, day 28
Percentage of neutrophils in the spontaneous sputum differential cell count
Time frame: Baseline, day 28
Differential cell count in induced sputum
macrophages, lymphocytes, eosinophils, basophils and epithelial cells
Time frame: Baseline, day 14 and 28
Differential cell count in spontaneous sputum
macrophages, lymphocytes, eosinophils, basophils and epithelial cells
Time frame: Baseline, day 14 and 28
Wet weight of spontaneous sputum
collected over a 24 hours period the day before each clinic visit
Time frame: Day -6, 0, 6, 13 and 27
Concentration of myeloperoxidase (MPO) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of myeloperoxidase (MPO) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of neutrophil elastase (NE) in induced sputum
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Time frame: Baseline, day 14 and 28
Concentration of neutrophil elastase (NE) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of interleukin-8 (IL-8) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of interleukin-8 (IL-8) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of leukotriene B4 (LTB4) in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of leukotriene B4 (LTB4) in spontaneous sputum
Time frame: Baseline, day 14 and 28
Concentration of albumin in induced sputum
Time frame: Baseline, day 14 and 28
Concentration of albumin in spontaneous sputum
Time frame: Baseline, day 14 and 28
Sputum bacterial load of induced sputum
Time frame: Baseline, day 14 and 28
Sputum bacterial load of spontaneous sputum
Time frame: Baseline, day 14 and 28
Sputum chemotactic activity of induced sputum
Time frame: Baseline, day 14 and 28
Sputum chemotactic activity of spontaneous sputum
Time frame: Baseline, day 14 and 28
Inhibition of blood neutrophil Mac-1 expression
both unstimulated and LTB4-stimulated
Time frame: Day 1 and 14
Inhibition of blood neutrophil chemotaxis response to LTB4
Time frame: Day 1 and 14
Forced expiratory volume in one second (FEV1)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Forced vital capacity (FVC)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Forced expiratory flow (FEF25-75%)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Peak expiratory flow rate (PEFR)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Inspiratory capacity (IC)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Slow vital capacity (SVC)
Time frame: Pre-treatment on Day 1, pre- and 30 min post-treatment on day 7 and 14
Changes in COPD symptom score
dyspnoea, fatigue, orthopnea, paroxysmal nocturnal dyspnoea and cough
Time frame: Baseline, Day 1, 7 and 14
Physician's global evaluation of symptoms assessed on a 4-point scale
Time frame: Baseline, Day 14
Number of patients with adverse events
Time frame: up to 6 weeks
Plasma concentrations of the analytes
Time frame: 30 min before, 90 and 240 min after drug administration on day 1 and 14