Control of Asthma Patients Symptomatic on Inhaled Corticosteroids

Inclusion Criteria: * a history of persistent asthma for at least the 4 months prior to entry * require daily inhaled corticosteroids (220-1000 µg fluticasone equivalent per day) for at least 4 weeks prior to randomization and short-acting beta-2-agonist (SABA) * FEV1 at randomization (without exposure to a SABA for at least 6 hours) must be between 50% and 80% of predicted normal * reversibility of FEV1 by at least 12% and at least 250 mL following two to four inhalations of a SABA must be demonstrated prior to randomization * AQLQ(S) score of 4.5 or less at both the screening (Visit 1) and randomization (Visit 2) visits * patients must meet at least two out of three of the following criteria: * overall score minimum of 2 on Asthma Control Questionnaire (ACQ) * require rescue SABA use of 2 or more inhalations per day for symptom relief on at least 4 of 7 days during each week of the baseline period * nighttime awakenings due to asthma, an average of at least once a week during the baseline period Exclusion Criteria: * history of chronic pulmonary diseases other than asthma, including bronchitis, chronic obstructive pulmonary disease (COPD), emphysema, cystic fibrosis, pulmonary tuberculosis, or bronchiectasis * other asthma therapies: * use of long-acting beta-2-agonists within 5 weeks prior to randomization * use of leukotriene modulators, theophylline, or muscarinic antagonists within 4 weeks prior to randomization * use of injectable or oral corticosteroids within 2 months prior to screening * requirement for more than 10 inhalations per day of a short-acting beta-2-agonist more than 3 times per week during the baseline period