4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma

Inclusion Criteria

• All patients must sign and date an Informed Consent consistent with International Conference on Harmonization Good Clinical Practices (ICH GCP) guidelines and local regulations prior to participation in the trial (i.e., prior to any study procedures, including washout of any medication) at Visit 1.
• Male or female patients greater to or equal to 18 years of age.
• Physician diagnosis of moderate-to-severe asthma (GINA Guidelines) existing for >1 year.
• Reversible airway obstruction (more than or equal to 12 % or at least 200 mL improvement in FEV1 post bronchodilator after 4 puffs of albuterol HFA MDI).
• Pre-bronchodilator clinic measured FEV1 ≤80% of predicted normal value (measured greater to or equal to 6 hours of the last use of short acting bronchodilator and greater to or equal to 12 hours after the last use of LABA if applicable).
• Continuous treatment with inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA) and other controller medication(s) for at least 6 weeks prior to screening (GINA 2007 Treatment Steps 3 to 5).
• No change in dos or regimen of ICS and LABA or other controller medications (including oral corticosteroids [OCS] if applicable), for at least 2 weeks prior to Visit 2.
• Use of short acting bronchodilator at least three times a week for symptom relief in the 2 weeks prior to Visit 1.
• Score of ≥1.5 points on the Asthma Control Questionnaire (ACQ) (see Appendix 10.6).
• Able to perform technically acceptable pulmonary function tests at the clinic and peak flow measurements with the eDiary/Peak Expiratory Flow Meter.
• Able to perform all necessary recordings (symptoms and as needed medication use) in the electronic diary, which is a part of the eDiary/Peak Expiratory Flow Meter.
• Investigator assessment of patients ability to inhale medication from a metered dose inhaler and RESPIMAT inhaler.

Exclusion Criteria

• Significant disease other than asthma not limited to diagnosis of COPD, such as, active tuberculosis, cystic fibrosis, alpha 1 antitrypsin deficiency, clinically significant bronchiectasis, interstitial lung disease, allergic bronchopulmonary aspergillosis, or constrictive bronchiolitis. 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, or (ii) influence the results of the study, or (iii) cause concern regarding the patient ability to participate in the study.
• History of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion 1.
• History of life-threatening asthma attack.
• Worsening of asthma that required treatment with an addition or increase in OCS dose (steroid burst) in the 4- week period prior to Visit 2.
• Current or ex-smokers who quit <1 year before enrollment. Ex-smokers who quit less than 1 year from enrollment must have a cigarette smoking history of less than 10 pack years.

Pack years = Number of cigarettes/day x years of smoking 20

• Use of oral beta-adrenergic agents within 4 weeks prior to screening.
• Treatment with inhaled ipratropium, ipratropium/albuterol combination, or nasal ipratropium within 1week of Visit 2.
• Treatment with inhaled tiotropium within 4 weeks of Visit 2.
• Known hypersensitivity to anticholinergic drugs, benzalkonium chloride (BAC), ethylenediaminetetracetic acid (EDTA) or any other components of the tiotropium inhalation solution or MDI.
• Known narrow-angle glaucoma.
• Clinically relevant abnormal hematology or blood chemistry at screening if the abnormality defines a significant disease as defined in exclusion criterion 1.
• Recent history (i.e., one year less) of myocardial infarction. Cardiac arrhythmias, newly diagnosed arrhythmias and/or any arrhythmia requiring an intervention (i.e., hospitalization, cardio version, pacemaker placement, and automatic implantable c