The purpose of this study is to assess the tolerability and efficacy of inhaled theophylline (ADC4022) on markers of pulmonary inflammation (white blood cells) in induced sputum and in bronchial biopsy samples in subjects with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) when co-administered with budesonide and compared to placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
91
Inhaled theophylline (ADC4022) administered twice daily for 28 days
Inhaled matching placebo administered twice daily for 28 days
Inhaled budesonide twice daily for 28 days
Silisian Medical University
Katowice-Ligota, Katowice-Ligota, Poland
Jagiellonian University of Medicine
Krakow, Krakow, Poland
National Tuberculosis and Lung Diseases Research Institute
Warsaw, Warsaw, Poland
Warsaw University Medical School
Warsaw, Warsaw, Poland
Pulmonary inflammation: Cell counts (neutrophils, macrophages, eosinophils and lymphocytes) in induced sputum samples
Time frame: Baseline and after 4 weeks treatment
Pulmonary inflammation: Cytokine IL-8 concentration in induced sputum
Time frame: Baseline and after 4 weeks treatment
Pulmonary inflammation: CD8+ and CD68+ from bronchial biopsy
Time frame: Baseline and after 4 weeks treatment
Tolerability to ADC4022
Time frame: Baseline, during 4 weeks treatment and after 1 week of follow-up
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Medical University in Lodz
Lodz, Łódź Voivodeship, Poland
Glenfield Hospital
Leicester, Leicestershire, United Kingdom
The London Chest Hospital
London, London, United Kingdom
Medicines Evaluation Unit
Manchester, Manchester, United Kingdom