Mc. Kopferschmittkubler et al., PROTECTIVE EFFECT OF NEDOCROMIL SODIUM ON THE DUAL ASTHMATIC RESPONSETO BRONCHIAL ANTIGEN CHALLENGE, Respiration, 60(1), 1993, pp. 21-26
The effects of nedocromil sodium and placebo on the asthmatic response
to antigen bronchial provocation were studied in a double-blind, rand
omized, crossover trial. Twelve subjects sensitized to Dermatophagoide
s pteronyssinus were challenged with successive doubling doses of this
allergen (1.25-80X10(-3) mg) on two separate occasions, at least 15 d
ays apart. A single dose of either nedocromil sodium 4 mg, or, a match
ing placebo was given 30 min before challenge. Forced expiratory volum
e in 1 s (FEV1) was measured 5, 10 and 15 min after challenge. Early a
sthmatic response was analyzed using three indices: dose producing a 2
0% decrease in FEV1 (PD20), the slope of and area under the dose-respo
nse curve. Nedocromil sodium was significantly superior to placebo wit
h respect to all three indices, providing significant inhibition of th
e early asthmatic responses. Seven of the 12 patients showed a late as
thmatic response. There was no significant difference between the effe
cts of nedocromil sodium and placebo treatments on the decline in peak
expiratory flow rate (PEFR) during the late asthmatic response but it
should be noted that when patients had been treated with nedocromil s
odium they were receiving two to eight times the dose of allergen give
n after placebo treatment.