Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Boehringer Ingelheim BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions 2.All patients must have a diagnosis of COPD (P06-12085) and must meet the following spirometric criteria: Patients must have relatively stable airway obstruction with a post-bronchodilator FEV1 =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; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient’s ability to participate in the study 2.Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT > x2 ULN, SGPT > x2 ULN, bilirubin > x2 ULN or creatinine > x2 ULN will be excluded regardless of clinical condition (a repeat laboratory evaluation will not be conducted in these patients) 3.Patients with a history of asthma. For patients with allergic rhinitis or atopy, source documentation is required to verify that the patient does not have asthma. If a patient has a total blood eosinophil count ??600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. A repeat eosinophil count will not be conducted in these patients. 4.Patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to the Screening Visit (Visit 1) or during the baseline period. 5.Patients with any of the following conditions: -a diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists) -a diagnosis of paroxysmal tachycardia (>100 beats per minute) (due to the known class side effect profile of ß2-agonists) 6.Patients with any of the following conditions: –a history of myocardial infarction within 1 year of screening visit (Visit 1) –unstable or life-threatening cardiac arrhythmia. –have been hospitalized for heart failure within the past year. –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 who have undergone thoracotomy with pulmonary resection (patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion No. 1) 8.Patients being treated with any of the 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 9.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 10.Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program 11.Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1) 12.Patients with known hypersensitivity to ß-adrenergics drugs, BAC, EDTA or any other component of the Respimat® inhalation solution delivery system 13.Pregnant or nursing women 14.Women of childbearing potential not using two effective methods of birth control (one barrier, one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilised by hysterectomy or bilatera
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to compare the 24-hour FEV1-time profile of BI 1744 CL inhalation solution administered once daily (5µg and 10 µg) or twice daily (2 µg and 5 µg) using the Respimat® Inhaler after 3 weeks of treatment. ;Secondary Objective: n/a;Primary end point(s): The primary efficacy variable will be forced expiratory volume in one second (FEV1). The co-primary efficacy endpoints are FEV1 AUC0-12 and FEV1 AUC12-24 after 3weeks of treatment. | — |
Countries
Belgium, Netherlands
Outcome results
None listed