Chronic Obstructive Pulmonary Disease MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Sponsors
Boehringer Ingelheim Finland Ky
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 chronic obstructive pulmonary disease 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 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 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 greater than 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. 4.Patients with a diagnosis of thyrotoxicosis or a diagnosis of paroxysmal tachycardia (>100 beats per minute) 5. Patients with: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 or a history of significant alcohol or drug abuse 6.Patients who have undergone thoracotomy with pulmonary resection 7.Patients being treated with: oral ß-adrenergics or 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 8. 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 9.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 10. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening visit (Visit 1) 11.Patients with known hypersensitivity to ß-adrenergics drugs, BAC, EDTA, lactose or any other component of the Respimat® inhalation solution or Aerolizer® DPI delivery system 12.Pregnant or nursing women 13.Women of childbearing potential not using two effective methods 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) delivered via the Respimat® inhaler, in patients with COPD. ;Secondary Objective: A key secondary efficacy analysis will be the effect of BI 1744 CL on patients’ health-related quality of life as determined by the total score from the Saint George’s Respiratory Questionnaire (SGRQ) after 24 weeks of treatment. The data from this trial and the replicate trial 1222.14 will be combined to examine this endpoint. ;Primary end point(s): There are three co-primary endpoints in this study: FEV1 AUC0-3h response, trough FEV1 response, and the Mahler TDI (focal score). The third co-primary endpoint, Mahler TDI (focal score) will be evaluated after combining the data from this and the replicate study 1222.14. The three endpoints will be evaluated after 24 weeks of treatment. •The bronchodilator efficacy of BI 1744 CL will be primarily assessed using forced expiratory volume in one second (FEV1). The co-primary endpoints will be FEV1 AUC0-3h response and trough FEV1 response. •The effect of BI 1744 CL on dyspnoea will be primarily assessed using the Mahler TDI focal score. | — |
Countries
Czech Republic, Denmark, Finland, Germany, Italy, Spain, Sweden
Outcome results
None listed