Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 8.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: BI 1744 solution for the use in Respimat Inhaler
Product Code: BI 1744 CL
Pharmaceutical Form:
Current Sponsor code: BI 1744 CL
Concentration type: equal
Concentration number: 1 µg/actu
Sponsors
Boehringer Ingelheim bv
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. All patients must have a diagnosis of chronic obstructive pulmonary disease (P06-12085) and must meet the following spirometric criteria: Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1 > 30% of predicted normal and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with a significant disease other than COPD; 2. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > 80 IU/L, SGPT > 80 IU/L, bilirubin > 17 µmol/L or creatinine >110 µmol/L (males) / 95 µmol/L (females) will be excluded regardless of clinical condition; 3. Patients with a history of asthma or a total blood eosinophil count ³ 600/mm3; 4. 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 QTc 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); 5. 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 (patients with treated basal cell carcinoma are allowed) –a history of life-threatening pulmonary obstruction –a history of cystic fibrosis –clinically evident bronchiectasis –a history of significant alcohol or drug abuse 7. Patients being treated with any of the following concomitant medications: –medications that prolong the QT/QTc interval –oral ß-adrenergics –ß-blockers (topical ß -blockers for ocular conditions are allowed) –oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations.;Secondary Objective: ;Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary endpoint is the trough FEV1 response [L] after four weeks of treatment. Trough FEV1 is defined as the mean of the two FEV1 values (performed at -1 hour and -10 minutes prior to test-drug inhalation) at the end of the dosing interval, 24 hours post-drug administration. Trough FEV1 response is defined as the change from baseline in trough FEV1. Baseline FEV1 is the mean of the two pre treatment FEV1 values measured at Visit 2 (- 1 hour and - 10 minutes) prior to administration of the first dose of study medication. | — |
Countries
Germany, Netherlands
Outcome results
None listed