Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 12.0 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Boehringer Ingelheim RCV GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: provision of informed consent diagnosis of chronic obstructive pulmonary disease post-bronchodilator FEV1 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Significant disease other than COPD Clinically relevant abnormal baseline hematology, blood chemistry, or urinalysis SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN History of asthma Following conditions:diagnosis of thyrotoxicosis, diagnosis of paroxysmal tachycardia (>100 beats per minute), a history of myocardial infarction within 1 year of screening visit (Visit 1), unstable or life-threatening cardiac arrhythmia. hospitalization for heart failure within the past year, known active tuberculosis, a malignancy (resection, radiation therapy or chemotherapy within last five years; treated basal cell carcinoma accepted), history of life-threatening pulmonary obstruction, a history of cystic fibrosis, clinically evident bronchiectasis and history of significant alcohol or drug abuse Undergone thoracotomy with pulmonary resection Following concomitant medications: oral ß-adrenergics, oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day, regularly use daytime oxygen therapy for more than one hour per day, completed pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or current pulmonary rehabilitation program, treatment with investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1) Known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, BAC, EDTA or any other component of the medications Pregnant or nursing women Women of childbearing potential not using two effective methods of birth control
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to determine the 24-hour FEV1-time profile of BI 1744 CL inhalation solution (5 µg and 10 µg) administered once daily by the Respimat® Inhaler after 6 weeks of treatment. ;Secondary Objective: A secondary objective is to compare the 24-hour FEV1-time profile of BI 1744 CL (5 µg and 10 µg) administered once daily by the Respimat® Inhaler with the 24-hour FEV1-time profile of tiotropium powder capsule (18 µg) administered once daily via the HandiHaler® after 6 weeks of treatment.;Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The primary objective will be to evaluate whether once daily treatment with 5 µg or 10 µg BI 1744 administered via the Respimat® device is superior to once daily treatment with Placebo using FEV1 AUC0-12 and FEV1 AUC12-24 responses after 6 weeks of treatment. The co-primary efficacy endpoints are FEV1 AUC0-12 response and FEV1 AUC12-24 response after 6 weeks of treatment. | — |
Countries
Denmark, Germany, Hungary
Outcome results
None listed