Am. J. Respir. Crit. Care Med., Vol 152, No. 6, 12 1995, 1879-1886.
The effect of nedocromil sodium on childhood asthma during the viral season
P Konig, H Eigen, MH Ellis, E Ellis, K Blake, D Geller, G Shapiro, M Welch and C Scott
Department of Child Health, University of Missouri-Columbia, USA.
Viral-induced symptomatic respiratory infections (SRI) frequently cause
exacerbations of asthma in children. This study investigated the protective
effects of 0.5% nedocromil sodium nebulizer solution given three times a
day in preventing asthma exacerbations associated with SRI. Ninety-three
mild-moderate asthmatic children (6 to 12 yr of age) received either 0.5%
nedocromil sodium or placebo for 24 wk during the viral season. The
nedocromil sodium group was symptom-free 58% of the days, and the
placebo-treated patients were symptom-free 45% of the days (p = 0.027).
During Weeks 1-12, significant differences favored nedocromil sodium for
asthma summary score (means: nedocromil sodium = 0.61, placebo = 0.92; p =
0.026), and daytime asthma (nedocromil sodium = 0.78, placebo = 1.22; p =
0.03). Significant differences were noted during monthly intervals for
cough (Weeks 1-4: nedocromil sodium = 0.61, placebo = 0.92, p = 0.027) and
peak expiratory flow rate (PEFR) (nedocromil sodium 262, placebo = 254
L/min, p = 0.041 Weeks 9-12). Patients in the active treatment group
reduced their need for rescue inhaled beta 2-agonist by 10%, whereas
patients treated with placebo demonstrated a 24% increase. There was a
strong correlation between asthma symptoms and SRI symptoms (r = 0.47; p
< 0.001). During SRIs, patients in the nedocromil sodium group
demonstrated more rapid resolution of asthma symptoms immediately following
infection (p = 0.033 summary score, p = 0.039 sleep difficulty). No serious
adverse events were noted. Nedocromil sodium did not prevent the infection
or exacerbation of asthma symptoms during SRI.(ABSTRACT TRUNCATED AT 250
WORDS)
