Protection against cold air and exercise-induced bronchoconstriction while on regular treatment with Oxis®

Abstract

This study aimed to compare the duration of protection against exercise-induced bronchoconstriction (EIB) after inhalation of formoterol (Oxis®) Turbuhaler® with that of terbutaline Turbuhaler® and placebo Turbuhaler® in asthmatic patients treated regularly with formoterol Turbuhaler® 9 μg b.i.d. and inhaled steroids. The study, performed at three centres (Göteborg and Lund, Sweden, and Trondheim, Norway), consisted of an open-label part with formoterol Turbuhaler® 9 μg b.i.d. and a randomized, double-blind, cross-over part with a single dose (on top of the regular treatment) of either formoterol Turbuhaler® 9 μg, terbutaline Turbuhaler® 0.5 mg or placebo Turbuhaler®. The patients attended the clinic six times: twice for screening visits, three times for randomized treatment and once for a follow-up visit. Patients received regular b.i.d. treatment with formoterol 9 μg for a mean period of 16 days. Formoterol gave a post-exercise fall of 12, 10, 15 and 17% in forced expiratory volume in 1 sec (FEV1) 15 min, 4, 8 and 12 h after inhalation. The differences compared with placebo (falls of 26, 22, 23 and 22%) and terbutaline (falls of 17, 18, 22 and 22%) were all statistically significant (P<0.05 for all comparisons). Patients on regular treatment with formoterol Turbuhaler® 9 μg b.i.d. have a significant protection against EIB up to 12 h after inhalation of formoterol 9 μg. The protection was also significantly better than that of terbutaline Turbuhaler® 0.5 mg. © 2001 Harcourt Publishers Ltd.