Formoterol fumarate is a new beta 2-adrenergic agonist with a long lasting effect. The bronchospasmolytic effect of 12 micrograms of
formoterol was compared with that of 200 micrograms of
albuterol (
salbutamol) in a single-center, double-blind, randomized within-patient study. The drugs were given as
aerosols by MDI to 16 patients with nocturnal
asthma in a stable phase. The inhalations were given
at 10 PM and the FEV1 values as parameter were measured before and at 1, 2, 6, 8, 10, and 12 hours afterwards. The FEV1 6 hours after administration of
formoterol was significantly higher than that after
albuterol (ANCOVA: p = 0.008), and this was still the case 12 hours after the test dose
at 10 AM the following morning (ANCOVA: p = 0.009). At 4 AM, the FEV1 fell below the basic starting value after
albuterol, whereas it remained at least 10 percent above the
formoterol inhalation. Five patients required rescue
therapy after
albuterol and two after
formoterol. We conclude that
formoterol in a dose of 12 micrograms via MDI confers good protection against nocturnal
asthma; this was only insufficient for some patients with severe
asthma, and further studies with higher dosages in these patients are clearly indicated.