Efficacy and Safety of 4 Weeks of Treatment With Orally Inhaled BI1744/Tiotropium Bromide in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive
Eligibility Criteria
Inclusion Criteria:
- All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:
Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 >= 30% of predicted normal and <80% of predicted normal and a post-bronchodilator FEV1 / FVC <70% at Visit 1
- Male or female patients, 40 years of age or older
- Patients must be current or ex-smokers with a smoking history of more than 10 pack years
- Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
- Patients must be able to inhale medication in a competent manner from the Respimat inhaler and from a metered dose inhaler (MDI).
- additional inclusion criteria apply.
Exclusion Criteria:
- Patients with a significant disease other than COPD
- Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis;
- Patients with a history of asthma or a total blood eosinophil count >= 600/mm3.
- Patients with any of the following conditions:a diagnosis of thyrotoxicosis, a diagnosis of paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTcF* interval > 450 ms), a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- Patients with any of the following conditions:a history of myocardial infarction within 1 year of screening visit (Visit 1), a diagnosis of clinically relevant cardiac arrhythmia, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, a history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis, a history of significant alcohol or drug abuse
- Patients who have undergone thoracotomy with pulmonary resection
- Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits.
- Pregnant or nursing women
- Women of childbearing potential not using two effective method of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years
- Patients who have previously been randomized in this study or are currently participating in another study
- Patients who are unable to comply with pulmonary medication restrictions prior to randomization
- Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit
- additional exclusion criteria apply.
Sites / Locations
- 1237.9.00152 Boehringer Ingelheim Investigational Site
- 1237.9.00155 Boehringer Ingelheim Investigational Site
- 1237.9.00151 Boehringer Ingelheim Investigational Site
- 1237.9.00154 Boehringer Ingelheim Investigational Site
- 1237.9.00153 Boehringer Ingelheim Investigational Site
- 1237.9.03253 Boehringer Ingelheim Investigational Site
- 1237.9.03255 Boehringer Ingelheim Investigational Site
- 1237.9.03254 Boehringer Ingelheim Investigational Site
- 1237.9.03251 Boehringer Ingelheim Investigational Site
- 1237.9.03252 Boehringer Ingelheim Investigational Site
- 1237.9.00255 Boehringer Ingelheim Investigational Site
- 1237.9.00251 Boehringer Ingelheim Investigational Site
- 1237.9.00252 Boehringer Ingelheim Investigational Site
- 1237.9.00254 Boehringer Ingelheim Investigational Site
- 1237.9.00253 Boehringer Ingelheim Investigational Site
- 1237.9.04952 Boehringer Ingelheim Investigational Site
- 1237.9.04953 Boehringer Ingelheim Investigational Site
- 1237.9.04954 Boehringer Ingelheim Investigational Site
- 1237.9.04955 Boehringer Ingelheim Investigational Site
- 1237.9.04959 Boehringer Ingelheim Investigational Site
- 1237.9.04960 Boehringer Ingelheim Investigational Site
- 1237.9.04958 Boehringer Ingelheim Investigational Site
- 1237.9.04951 Boehringer Ingelheim Investigational Site
- 1237.9.04956 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
BI 1744 CL low dose+tiotropium bromide
BI 1744 CL medium dose+tiotropium bromide
BI 1744 CL low dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation
BI 1744 CL medium dose plus tiotropium bromide fixed dose combination; Solution for inhalation via Respimat® Inhaler (A5); Oral inhalation