A Randomised, Double-Blind, Double-Dummy, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 48 Weeks of Once Daily Treatment of Orally Inhaled BI 1744 CL (5 µg [2 actuations of 2.5 µg] and 10 µg [2 actuations of 5 µg]) Delivered by the Respimat® Inhaler, and 48 Weeks of Twice Daily Foradil® (12 µg) Delivered by the Aerolizer® Inhaler, in Patients with Chronic Obstructive Pulmonary Disease (COPD).

Conditions: Chronic Obstructive Pulmonary Disease
MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPD

Registration Number: EUCTR2008-001933-84-DK

Lead Sponsor: Boehringer Ingelheim Danmark A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 860

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 <80% of predicted normal (ECSC) and a post-bronchodilator FEV1/FVC<70% at Visit 1
3.Male or female patients, 40 years of age or older
4.Patients must be current or ex-smokers with a smoking history of more than 10 pack years
5.Patients must be able to perform technically acceptable pulmonary function tests and PEF measurements, and must be able to maintain records (Patient Daily e-Diary) during the study period as required in the protocol
6.Patients must be able to inhale medication in a competent manner from the Respimat® inhaler, a dry powder inhaler and from a metered dose inhaler

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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