The aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe COPD. Moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
492
One 300 mg capsule twice a day
One capsule twice a day
number of acute exacerbations
Time frame: 12 months
spirometry parameters
Time frame: 12 months
COPD symptoms
Time frame: 12 months
Quality of life
Time frame: 12 months
Safety and tolerability of erdosteine
Time frame: 12 months
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