J. Vilsvik et al., Protection against cold air and exercise-induced bronchoconstriction whileon regular treatment with Oxis((R)), RESP MED, 95(6), 2001, pp. 484-490
This study aimed to compare the duration of protection against exercise-ind
uced bronchoconstriction. (EIB) after inhalation of formoterol (Oxis (R)) T
urbuhaler (R) with that of terbutaline Turbuhaler (R) and placebo Turbuhale
r (R) in asthmatic patients treated regularly with formoterol Turbuhaler (R
) 9 mug b.i.d. and inhaled steroids.
The study, performed at three centres (Goteborg and Lund, Sweden, and Trond
heim, Norway), consisted of an open-label part with formoterol Turbuhaler (
R) 9 mug b.i.d. and a randomized, double-blind, cross-over part with a sing
le dose (on top of the regular treatment) of either formoterol Turbuhaler (
R) 9 mug, terbutaline Turbuhaler (R) 0.5mg or placebo Turbuhaler (R). The p
atients attended the clinic six times: twice for screening visits, three ti
mes for randomized treatment and once for a follow-up visit. Patients recei
ved regular b.i.d, treatment with formoterol 9 mug for a mean period of 16
days.
Formoterol gave a post-exercise fall of 12, 10, 15 and 17% in forced expira
tory volume in 1 sec (FEV1) 15 min, 4, 8 and 12h after inhalation. The diff
erences 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 (R) 9 mug b.i.d. h
ave a significant protection against EIB up to 12h after inhalation of form
oterol 9 mug. The protection was also significantly batter than that of ter
butaline Turbuhaler (R) 0.5 mg.