THE DURATION OF ACTION OF INHALED FORMOTEROL DRY POWDER

Abstract

SUMMARY The duration of action of formoterol inhaled as a dry powder formulation is compared with placebo and a reference treatment of salbutamol dry powder in patients with bronchial asthma. This single‐centre, double‐blind, cross‐over study recruited 23 outpatients with clinically stable asthma. These patients were treated with 12μg formoterol, 400μg salbutamol or placebo in a randomly allocated sequence, with at least 2 days between treatments. Forced expiratory volume in 1s of expiration (FEV1) was measured at specified time points from 15 min to 15 hours post‐treatment. Formoterol produced significantly higher values of FEV1 at the primary endpoint of 12 hours compared with placebo and salbutamol. No differences between FEV1 values were seen for the active treatments of formoterol and salbutamol for the first 5 hours post‐inhalation. Formoterol was significantly superior to placebo at all time points, whereas salbutamol was significantly superior to placebo for the first 5 hours.This study demonstrates that formoterol, when given as a dry powder inhalation, has a significantly longer duration of acute bronchodilator action than 400μg salbutamol inhaled as a dry powder. The duration of action of formoterol of at least 12 hours seen in this study is at least as long as that reported following administration from a metered dose inhaler (MDI) at the same dose level. The study also demonstrates that 12μg formoterol dry powder is well tolerated by patients.