Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Code: BI 1744/tiotropium 1 µg/2.5 µg FDC
Pharmaceutical Form: Inhalation vapour, solution
Other descriptive name: BI1744 plus tiotropium fixed dose combination
Concentration unit: µg microgram
Sponsors
Boehringer Ingelheim GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Dagnosis of COPD. Relatively stable airway obstruction with post-bronchodilator FEV1 =30% of predicted normal and 10 pack-years. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Significant disease other than COPD. Abnormal baseline laboratory results. History of asthma or total blood eosinophil count =600/mm3. Thyrotoxicosis. Paroxysmal tachycardia (>100 beats per minute). Marked baseline prolongation of QT/QTc interval. History of additional risk factors for Torsade de Pointes (TdP). History of myocardial infarction within 1 year of screening visit (Visit 1). Clinically relevant cardiac arrhythmia. Known active tuberculosis. Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last 5 years (patients with treated basal cell carcinoma are allowed). History of life-threatening pulmonary obstruction. History of cystic fibrosis. Clinically evident bronchiectasis. History of significant alcohol or drug abuse. Regular daytime oxygen. Rehabilitation programme within 6 weeks prior to start of study or during study. Administration of investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit. Known hypersensitivity to ß-adrenergics and/or anticholinergic drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system. Pregnant or nursing women. Women of childbearing potential not using two highly effective methods of birth control (one barrier and one non-barrier). Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the optimum dose(s) of BI 1744 CL administered as a fixed combination with 5 µg tiotropium bromide solution for inhalation, delivered by the Respimat® inhaler, once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD).;Secondary Objective: Bronchodilator efficacy, safety evaluations and pharmacokinetic evaluation. ;Primary end point(s): Trough FEV1 response [L] after four weeks of treatment. | — |
Countries
Germany
Outcome results
None listed