Health Condition 1: null- Chronic Obstructive Pulmonary Disease
Conditions
Interventions
Intervention1: BI 1744 CL: 5 microgram and 10 microgram, Once daily, 48 weeks (oral Inhalation)
Control Intervention1: Formoterol: 12 microgram, twice daily, 48 weeks (oral Inhalation)
Sponsors
Boehringer Ingelheim Shanghai Pharmaceuticals Co Ltd
Quintiles Research India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1<80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC <70% at Visit 1 2. Male or female patients, 40 years of age or older 3. Patients must be current or ex-smokers with a smoking history of more than 10 pack years:
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 patientâ??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 >=ï? 600/mm3, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition. 4. Patients with any of the following conditions: - a diagnosis of thyrotoxicosis (due to the known class side effect profile of Ã?2-agonists) - a diagnosis of paroxysmal tachycardia ( >100 beats per minute) (due to the known class side effect profile of Ã?2-agonists) 5. 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 6. 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) 7. Patients being treated with any of the following concomitant medications: - oral β-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 8. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigatorâ??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 β-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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objectives: There are 3 co primary endpoints: FEV1 AUC 0 to 3hr response, trough FEV1 response and the Mahler TDI (focal score: combined with 1222.14 trial) 24 Weeks. Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objectives: FEV1 AUC response after 2, 6, 12 and 48 weeks FEV1 trough after 2, 6, 12, 18, 24, 32, 40 and 48 weeks FEV1 peak SGRQ after 12 and 48 weeks 48 WeeksTimepoint: 2, 6, 12, 18, 24, 32, 40 and 48 weeks | — |
Countries
Argentina, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, Germany, Hong Kong, India, Italy, Malaysia, Mexico, Netherlands, Norway, Philippines, Republic of Korea, South Africa, Spain, Sweden, Thailand, Ukraine
Contacts
Public ContactSuchela Srivatsa
IQVIA RDS (India) Private Limited
Outcome results
None listed