Table 1.

Criteria for Assigning Status of Control and Inadequate Control of Asthma during both run-in and the double-blind treatment period

Control: At-home measurements: Symptoms, albuterol use, or PEF <80% baseline occurring 3 days or less on average per week over 2 weeks; nocturnal awakenings less than 2 days for the 2 weeks, and In-clinic measurements: PRE bronchodilator FEV1 value ≥80% best PRE bronchodilator value obtained during run-in. Inadequate control: Appearance of increased symptoms or decreased pulmonary function: At-home measurements: Days with symptoms, albuterol use for symptoms or low PEF, or PEF <80% baseline more than 3 days/week on average over 2 weeks; nocturnal awakening 2 or more nights over 2 weeks. In-clinic measurements:PRE bronchodilator FEV1 values on 2 consecutive sets of spirometric determinations 1–4 days apart that are < 80% of the best PRE bronchodilator value obtained prior to randomization. Exacerbation of asthma as determined by symptoms of cough, dyspnea, chest tightness, wheeze, and/or PEF less than 80% of their personal best not responding to an increase in inhaled short acting bronchodilator with need for oral corticosteroid therapy.