Study on BI 54903 (Inhaled Corticosteroid) Administered Once Daily or Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroids

Exclusion Criteria

• •Patients with significant pulmonary disease other than asthma or other significant medical conditions (as determined by medical history, examination and clinical investigations at screening) that may, in the opinion of the investigator, result in any of the following: (i) put the patient at risk because of participation in this trial or (ii) influence the results of the trial or (iii) cause concern regarding the patient's ability to participate in the trial.
• •Patients with a clinically relevant, abnormal screening haematology and/or blood chemistry finding, if the abnormality indicates a significant disease as defined in exclusion criterion no. 1.
• •Patients with a history of upper or lower respiratory tract infection (URTI/LRTI) in the past four weeks prior to the pre-screening Visit 1, and during pre-screening and run-in periods.
• •Patients with any exacerbation of their underlying asthma during the eight weeks prior to the pre-screening Visit 1.
• •Patients with active allergic rhinitis requiring treatment with systemic corticosteroids.
• •Any of the following criteria are met during the pre-screening / run-in period (Visits 1 - 6):
• •in clinic pre-bronchodilator FEV1 % predicted less than 40%,
• •more than 12 puffs rescue salbutamol/albuterol HFA MDI per day for \> 2 consecutive days,
• •exacerbation of asthma.
• •Patients with a history of pneumonectomy or who are planning to undergo thoracotomy for any reason.
• •Patients who are currently in a pulmonary rehabilitation program or have completed a pulmonary rehabilitation program in the six weeks prior to the first screening visit 1.
• •Patients with two or more hospitalizations for asthma within the previous 12 months.
• •Patients with a recent history of myocardial infarction during the last twelve months or known coronary heart disease that requires treatment
• •Patients with a history of hospitalisation due to heart failure in the past twelve months
• •Patients with myocarditis or any unstable or life-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
• •Patients with significant alcohol or drug abuse in the opinion of the investigator within the past two years
• •Patients with rheumatoid arthritis or other systemic diseases that require immune system modulating treatment
• •Patients suffering from or with a history of glaucoma, increased intraocular pressure, and/or cataracts
• •Pregnant or nursing women
• •Women of childbearing potential not using a highly effective method of birth control.
• •Patients who have been treated with anti-IgE-antibodies (e.g. omalizumab - Xolair®) or other immune system modulating antibodies such as TNF-alpha blockers within six months prior to Visit 1.
• •Patients who have been treated with the following drugs during the past four weeks prior to Visit 1 or are foreseen to need this during the study:
• •Non-selective ß-blockers (topical cardio-selective beta-blocker eye medications for non-narrow angle glaucoma are allowed),
• •Oral or other systemic corticosteroids,
• •Oral beta-agonists,
• •Changes in allergen desensitisation therapy in last 6 months,
• •Immune system modulating agents such as methotrexate or cyclosporine,
• •Inhibitors of cytochrome P450 3A4 such as antifungals (e.g. ketoconazole, itraconazole), antibiotics (e.g. erythromycin) or antiretroviral drugs.
• •Patients who have been treated with leukotriene modifiers, cromones or theophylline within two weeks prior to Visit 1.
• •Patients who have been treated with tiotropium within 3 weeks prior to Visit 1.