Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD

Inclusion criteria

• Signed informed consent consistent with ICH-Good Clinical Practice (GCP) guidelines and local legislation prior to participation in the trial. Medication washout and medication restrictions are allowed only after signed informed consent is obtained.
• Males or females not of childbearing potential between 40 and 80 years (each inclusive) of age, on the day of patient´s signature of informed consent.
• All patients must have a documented diagnosis of COPD according to Global Initiative for Chronic Obstructive Lung Disease (GOLD).
• Post-bronchodilator forced expiratory volume (FEV)1 of >=40% and 450 ms), pulse/heart rate outside 50 to 90 bpm at Visit 1 (if confirmed by pulse rate measurement over 60 seconds), or any other relevant ECG finding.
• Patients with a history of additional risk factors for Torsades de Pointes (such as heart failure, hypokalemia, or family history of Long QT Syndrome).
• Patients with known active tuberculosis.
• Patients with clinically relevant bronchiectasis, as assessed by the investigator.
• Patients with any respiratory infection (such as common cold, acute sinusitis, or similar illnesses) or COPD exacerbation within 6 weeks prior to the screening visit (Visit 1) or between the screening visit and randomization.
• Patients who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1).
• Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed to participate.
• Patients with a history of and/or active significant alcohol or drug abuse as assessed by the investigator.
• Patients who are being treated with non-permitted concomitant medication.
• Patients who have taken an investigational drug within 4 weeks prior to Visit 1 or if screening occurs within six half-lives of intake of another investigational drug (whichever is greater).
• Patients with surgery of the gastrointestinal tract that could interfere with kinetics of the trial medication as assessed by the investigator.
• Patients with veins unsuited for venipuncture (for instance, veins which are difficult to locate, access or puncture, veins with a tendency to rupture during or after puncture) as assessed by the investigator.
• Patients who are unable to comply with the dietary regimen.
• Patients who have been previously randomized in this study.
• Patients who have donated more than 100 mL blood in the 4 weeks prior to Visit 1 and between Visit 1 and Visit 3 or patients who have the intention to donate blood between Visit 3 and four weeks after the end of trial visit.
• Patients who are pregnant or breastfeeding
• Male patients who do not agree to minimize the risk of female partners becoming pregnant from the first dosing day until 3 months after the trial medication treatment has finished.
• Patient is assessed as unsuitable for inclusion by the investigator; for instance, because he or she is not considered to comply with study requirements