Study to Evaluate Safety and Efficacy of Inhaled Bimosiamose for the Treatment of Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Inclusion criteria

• Male and postmenopausal or sterile female patients with a history of moderate to severe COPD defined as Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-III for at least 1 year
• At least 40 years of age
• Current smoker or ex-smoker with at least 10 pack-year smoking history (Ten pack-years is defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.)
• Postbronchodilator FEV1 between 30% and 80% predicted and FEV1/FVC ratio < 70%. Postbronchodilator refers to 30 min after inhalation of 400 µg Salbutamol. This criterion for FEV1 will have to be demonstrated after a washout period of at least 48 h during which no long acting anticholinergic medication (LAMA) or long acting β2-agonists (LABA) has been inhaled or a washout period of 6 h during which no short acting β2-agonists (SABA) or anticholinergic medication (SAMA) has been inhaled. For patients having been pretreated with an inhaled corticosteroid (ICS) and/or theophylline, this criterion needs to be demonstrated after a washout of at least 4 weeks.
• Able to produce sputum upon induction in a sufficient quality. This criterion will be checked by the responsible sputum lab prior to randomization of the patient.
• Time and ability to complete the study
• Able to communicate well with the investigator, to understand and comply with the requirements of the study. Understand and sign the written informed consent.

Exclusion criteria

• Patients with a history of chronic respiratory disorders other than COPD e.g. asthma, α1-Antitrypsin deficiency, mucoviscidosis, lung fibrosis
• Patients who experienced an exacerbation in the 4 weeks before the screening visit or between screening and randomization
• Patients who experienced an acute upper respiratory tract infection or broncho-pulmonary infection requiring antibiotic treatment during the 4 weeks before the screening visit or between screening and randomization
• Treatment with inhaled (ICS), topical or any systemic corticosteroids or theophylline within at least 4 weeks before the screening visit and throughout entire course of the study. Patients with ICS and/or theophylline treatment will undergo a washout of at least 4 weeks after signature of the informed consent and prior to the screening visit, where eligibility to enter the study will be assessed