Efficacy (Bronchoprotection) and Safety of Orally Inhaled BI 1744 CL in Patients With Intermittent Asthma

Inclusion criteria

• Diagnosis of intermittent asthma according to Global Initiative for Asthma criteria
• Non-smokers or ex-smokers who have not smoked for at least 1 year and have a smoking history of less than 5 pack-years
• Forced Expiratory Volume in 1second greater than or equal to 80% predicted normal (Visit 1).
• Bronchial hyperresponsiveness to inhaled methacholine with a provocative concentration of a methacholine causing a 20% fall in Forced Expiratory Volume in one second less than or equal to 8 mg/mL (Visit 1).
• Be able to perform technically acceptable pulmonary function tests
• Be able to inhale medication in a competent manner from the Respimat® inhaler
• Must sign and date an informed consent consistent with International Conference on Harmonisation-Good Clinical Practice guidelines prior to participation in the trial, which includes medication washout and restrictions.

Exclusion criteria

• Patients with a significant disease other than asthma
• Patients with seasonal asthma or allergies whose participation in the trial will occur during the season for which they are allergic.
• Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with a serum glutamic oxaloacetic transaminase > 80 IU/L, serum glutamic pyruvic transaminase > 80 IU/L, bilirubin >2.0 mg/dL or creatinine > 2.0 mg/dL will be excluded regardless of clinical condition
• Patients with any of the following conditions: a diagnosis of hyperthyrosis or paroxysmal tachycardia (>100 beats per minute), a marked baseline prolongation of QT/QTc interval, a history of additional risk factors for Torsade de Pointes, a history of myocardial infarction, a diagnosis of clinically relevant cardiac arrhythmia, a history of cor pulmonale, known active tuberculosis, a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the 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.
• Patients who have undergone thoracotomy with pulmonary resection
• Patients who are being treated with any of the following concomitant medications: medications that prolong the QT/QTc interval, oral beta-adrenergics, beta-blockers or monoamine oxidase inhibitors or tricyclic antidepressants.
• Patients who have been treated with any respiratory medications (excluding short-acting beta-agonists) for control of their asthma symptoms within 3 months of the Screening Visit (Visit 1).
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1).
• Pregnant or nursing women, or women of childbearing potential not using a highly effective method of birth control.