Safety, Tolerability and Pharmacokinetics and Effect on Inflammation of Oral BI 1026706 in Patients With COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive; Inflammation
Intervention: BI 1026706; Placebo; Placebo
Intervention description: For blinding purposes
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 120.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The main objective of the current trial is to investigate safety, tolerability,
      pharmacokinetics and effect on inflammation of oral BI 1026706 administered twice daily for 4
      weeks in patients with COPD.
    

Eligibility criteria:

        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 <=90% of predicted
             normal at Visit 1

          -  Post-bronchodilator FEV1/forced vital capacity (FVC) <70% at Visit 1

          -  Patients must be current or ex-smokers with a smoking history of more than 10 pack
             years

          -  Patients on stable respiratory medications for at least 6 weeks prior to randomization
             (Visit 3).

          -  Patients must be able to perform technically acceptable pulmonary function tests.

        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:

               1. Put the patient at risk because of participation in the study

               2. Influence the results of the study

               3. Cast doubt on the patients ability to participate in the study

          -  Patients with current asthma. For patients with allergic rhinitis or atopy, source
             documentation is required to verify that the patient does not have asthma.

          -  Patients with clinically relevant abnormal hematology, blood chemistry, or urinalysis
             at the screening visit (Visit 1), if the abnormality indicates a relevant disease as
             defined in exclusion criterion number 1. Safety laboratory screening evaluation (Visit
             1) can be repeated a maximum of two times.

          -  Patients with a history of myocardial infarction or apoplexy within 6 months of the
             screening visit (Visit 1) or between the screening visit (Visit 1) and randomization.

          -  Patients with a history of and/or active life-threatening cardiac arrhythmia, as
             assessed by the investigator.

          -  Patients with a marked baseline prolongation of QT/QTcB interval (such as repeated
             demonstration of a QTcB interval >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