Am. J. Respir. Crit. Care Med., Vol 152, No. 6, Dec 1995, 1887-1892.
Long-term circadian effects of salmeterol in asthmatic children treated with inhaled corticosteroids
GG Meijer, DS Postma, PG Mulder and WM van Aalderen
Department of Pediatric Pulmonology, Beatrix Children's Hospital, University Hospital Groningen, The Netherlands.
The present study was set up to investigate whether salmeterol in children
with asthma already treated with inhaled corticosteroids (ICS) leads to a
sustained bronchodilator effect and decreased bronchial responsiveness,
both during the day and night. Furthermore, we investigated whether
cessation of salmeterol leads to a rebound increase in bronchial
responsiveness. Forty children with asthma (aged 7-15 yrs) using ICS
participated in a randomized, double-blind, parallel study. They received
either twice daily 50 micrograms salmeterol or placebo. FEV1 and
provocative concentration of methacholine that caused a 20% fall in FEV1
(PC20) were measured at 4:00 P.M. and 4:00 A.M. at baseline and after 16
wk. The same measurements were performed at 4:00 P.M. at 8 h after the
first dose, and after 1 and 8 wk. After cessation of the study drug, FEV1
and PC20 were measured at 12 and 20 h and after 1 wk. Overall mean FEV1
from 1 to 16 wk of treatment was significantly higher in the salmeterol
group than in the placebo group (difference, 4.9 +/- 2.0%, p = 0.01).
Evolution in time of FEV1 did not differ significantly between the two
groups (p = 0.09). Overall mean PC20 from 1 to 16 wk of treatment was not
significantly higher with salmeterol than with placebo (difference, 0.7 +/-
0.4 doubling dose [DD] p = 0.07); evolution in time of PC20 did not differ
significantly between the two groups (p = 0.58).(ABSTRACT TRUNCATED AT 250
WORDS)
