We compared the efficacy of inhaled formoterol, a long-acting beta-2-agonist, while inhaled albuterol in 145 stable adult asthmatics in a 12-wk multicenter trial. Patients were allocated in randomized double-blind fashion to maintenance therapy with either formoterol 12-mu-g twice a day or albuterol 200-mu-g four times a day in addition to their other asthma medications. Patients were allowed to use "rescue" 100-mu-g albuterol puffs on an as-needed basis. Mean baseline FEV1 in the morning before bronchodilator was 2.14 +/- 0.76 L and 1.98 +/- 0.71 L for the formoterol and albuterol groups, respectively, these values being used as baseline covariates in subsequent analysis of predrug and postdrug FEV1. Measured at each clinic visit, morning predrug FEV1 rose significantly with formoterol treatment and was significantly greater at all visits than in the albuterol group, the greatest difference being in Week 8 (2.40 +/- 0.77 versus 1.92 +/- 0.66 L, p < 0.001). Morning FEV1 30 min postdrug was significantly higher in the formoterol group at Weeks 2 and 8, the trend not reaching statistical significance at other times. Diurnal variation in prebronchodilator peak flow rates was significantly reduced in the formoterol group throughout the trial (17 versus 42 L/min at Week 12, p < 0.0001). The number of asthma episodes per week was significantly less in the formoterol group during Weeks 4, 8, and 12 as were the number of sleep disruptions during Weeks 2, 4, 6, 8, and 12. Significantly more rescue albuterol was required in the albuterol group by Week 2 and throughout the remainder of the study. Adverse reaction ratings and withdrawals were not significantly different between groups. We conclude that regular twice-daily inhalation of formoterol is more effective than inhalation of albuterol four times daily in reducing diurnal fluctuations in airway caliber, the number of symptomatic episodes, and the perceived need for additional inhaled bronchodilator.
