BI 113608 Administered as Tablets Twice Daily Over 4 Weeks in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis

Inclusion criteria

• All patients must sign an informed consent consistent with ICH-GCP guidelines and local legislations prior to any study-related procedures, which includes medication washout and restrictions.
• All patients must have a documented diagnosis of COPD according to GOLD 2013.
• Post-bronchodilator 50% = FEV1 < 80% of predicted at screening visit.
• Post-bronchodilator FEV1/FVC <70% at screening visit.
• Patients must have a history of chronic bronchitis as defined by symptoms of cough and sputum production on most days during at least three months for the past two consecutive years.
• CAT Questionnaire at screening: a score of at least one for both cough (1st question) and sputum (2nd question).
• Males and females between 40 and 80 years (inclusive) of age, on the day of patient´s signature of informed consent.
• Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
• Patients must be able to perform technically acceptable pulmonary function tests (body plethysmography, forced spirometry and DLCO measurement).
• Females must be of non-childbearing potential. Women of non-childbearing potential are defined as those who have undergone bilateral ovariectomy, bilateral salpingectomy or hysterectomy. If so, documentation confirming the surgical procedure must be available on the patient's source documents. A woman is also presumed to be infertile due to natural causes if she has been amenorrheic for more than 24 months. In questionable cases, a blood analysis of FSH and estradiol, which indicates the postmenopausal status according to the central laboratory ranges for postmenopausal females, is considered confirmatory.

Exclusion criteria

• Significant pulmonary disease other than COPD or other medical conditions* (as determined by medical history, examination, and clinical investigations at screening) that may, in the opinion of the investigator, result in the any of the following:

• Put the patient at risk because of participation in the study,
• Influence the results of the study,
• Cause concern regarding the patient's ability to participate in the study. (*e.g. cardiac, gastro-intestinal, hepatic, renal, metabolic, dermatologic, neurological, haematological, oncological and psychiatric; history of relevant orthostatic hypotension, fainting spells or blackouts; current chronic or relevant acute infections.)
• Patients with any lung disease other than COPD (e.g. asthma, interstitial lung disease (ILD), cystic fibrosis, active tuberculosis, post-TB syndrome, clinically evident bronchiectasis, with a history of thoracotomy with pulmonary resection).
• Patients with clinically relevant abnormal haematology, blood chemistry, or urinalysis at screening visit (Visit 1), if the abnormality defines a relevant disease as defined in exclusion criterion number 1.
• All patients with a serum glutamate oxaloacetate transferase (SGOT) or serum glutamic pyruvic transaminase (SGPT) or total bilirubin higher than 1.5-fold ULN or serum creatinine higher than normal at Visit 1 (and at all repeated tests, if applicable) will be excluded regardless of the clinical condition. Laboratory evaluation can be repeated maximum two times.
• A malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years (patients with treated basal cell carcinoma are allowed).
• Patients with current relevant psychiatric disorders based on the investigator´s judgement.
• Patients with any respiratory infection (e.g. common cold, sinusitis, etc.) or COPD exacerbation within the six weeks prior to the screening visit (Visit 1) or between screening visit and randomization.
• Patients with a history of two or more moderate or severe COPD exacerbations per year within the last two years.
• Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion number 1.
• Patients who are being treated with non-permitted concomitant medication.
• Patients with a recent history (i.e. three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
• Patients who have previously been randomised in this trial.
• Current participation in another clinical trial (as defined in the ICH Harmonised Tripartite Guideline for Good Clinical Practice (GCP)).
• Donation of more than 100 mL of blood within the past four weeks prior to screening.
• A history of additional risk factors for torsade-de-pointes (e.g., heart failure, relevant hypokalemia, family history of Long QT Syndrome).
• Pregnant or nursing women.
• Gastrointestinal tract surgery that might affect absorption and elimination of drugs.
• Patients with known hypersensitivity / allergy to the investigational medicinal product (IMP) or its excipients.
• Male Patients who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until two months after study completion.