Long-term efficacy of formoterol compared to salbutamol.

In a randomized, double-blind, between-patient, multicenter study in 301 patients with ROAD, the efficacy and tolerability of the new long-acting selective beta 2-sympathicomimetic drug formoterol (12 micrograms inhalation b.i.d.) was compared with salbutamol (200 micrograms inhalation q.i.d.). There was no statistically significant (s.s.) difference in acute reversibility and long-term efficacy of both drugs, measured by the point in time of expected maximal effect. However, formoterol had a highly s.s. longer duration of action than salbutamol, as shown by peak expiratory flow (PEF) measurements: the overall mean morning PEF in the formoterol group was 341 L/min. 14 h after the last taken dose and in the salbutamol group this measure was 304 L/min 9 h after the last dose. The patients taking formoterol had s.s. less asthma attacks and needed s.s. less rescue medication than those taking salbutamol. In the global assessment of efficacy, formoterol was accepted as being s.s. better ("very good" + "good": 76%) than salbutamol ("very good" + "good": 50%). The tolerability of each drug, as reflected by adverse reactions and global assessment, was equally good in both groups. Ninety-one percent of the patients in the formoterol group wanted to receive the same drug again versus 79% in the salbutamol group.

RCT Entities:   Population Interventions Outcomes