The effect of nedocromil sodium on childhood asthma during the viral season.
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)
König
P
P
Department of Child Health, University of Missouri-Columbia, USA.
Eigen
H
H
Ellis
M H
MH
Ellis
E
E
Blake
K
K
Geller
D
D
Shapiro
G
G
Welch
M
M
Scott
C
C
D018927:Anti-Asthmatic Agents / Q000627:therapeutic use*; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology; D001985:Bronchial Provocation Tests; D002648:Child; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D016210:Methacholine Chloride; D017835:Nedocromil / Q000627:therapeutic use*; D010366:Peak Expiratory Flow Rate; D012141:Respiratory Tract Infections / Q000150:complications*; D014777:Virus Diseases / Q000150:complications*
D018927:Anti-Asthmatic Agents; D017835:Nedocromil; D016210:Methacholine Chloride