Efficacy and Safety of Tiotropium and Salmeterol in Moderate Persistent Asthma Patients Homozygous for B16-Arg/Arg

Inclusion\_Criteria:

• Patients homozygous for arginine at the 16th amino acid position of the beta2 adrenergic receptor (B16 Arg/Arg)
• All patients must sign and date an Informed Consent Form for the study prior to participation in the trial
• Male or female outpatients with at least 18 years of age, but not older than 65 years
• Patients must have a documented history of asthma
• Patients must be current non-smokers or ex-smokers with a cigarette smoking history of <10 pack-years
• Patients must be on a maintenance treatment with inhaled corticosteroids with a total daily dose of 400 - 1000 mcg budesonide or equivalent

Exclusion\_Criteria:

• Patients with a significant disease other than asthma
• Patients with a recent history (i.e., six months or less) of myocardial infarction
• Patients who have been hospitalized for heart failure (New York Heart Association class III or IV) within the past year
• Patients with any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year
• Patients with 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.
• Patients with a diagnosis of chronic obstructive pulmonary disease (COPD)
• Patients with a history of life threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis
• Patients with known active tuberculosis
• Patients who have undergone thoracotomy with pulmonary resection.
• Patients who have completed a pulmonary rehabilitation program in the six weeks prior to visit 1 or patients who are currently in a pulmonary rehabilitation program that will not be maintained throughout the duration of the study.