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About
The main objective of the current trial is to investigate safety, tolerability and pharmacokinetics of BI 113608 in COPD patients with symptoms of chronic bronchitis.
Enrollment
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Inclusion criteria
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:
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.
Primary purpose
Allocation
Interventional model
Masking
84 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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