Efficacy of fluticasone propionate on lung function and symptoms in wheezy infants.
The role of inhaled corticosteroids in the treatment of recurrent or persistent wheeze in infancy remains unclear. We evaluated the effect of 3 months of treatment with inhaled fluticasone propionate, 200 microg daily (FP200), on lung function and symptom scores in wheezy infants. Moreover, we evaluated whether infants with atopy and/or eczema respond better to FP200 as compared with non-atopic infants. Forced expiratory flow (Vmax(FRC)) was measured at baseline and after treatment. Sixty-five infants were randomized to receive FP200 or placebo, and 62 infants (mean age, 11.3 months) completed the study. Mean Vmax(FRC), expressed as a Z score, was significantly below normal at baseline and after treatment in both groups. The change from baseline of Vmax(FRC) was not different between the two treatment arms. After 6 weeks of treatment, and not after 13 weeks, the FP200 group had a significantly higher percentage of symptom-free days and a significant reduction in mean daily cough score compared with placebo. Separate analysis of treatment effect in infants with atopy or eczema showed no effect modification. We conclude that in wheezy infants, after 3 months of treatment with fluticasone, there was no improvement in lung function and no reduction in respiratory symptoms compared with placebo.
Hofhuis
Ward
W
Division of Respiratory Medicine, Department of Pediatrics, Erasmus University MC/Sophia Children's Hospital, P.O. Box 2060, 3000 CB Rotterdam, The Netherlands.
van der Wiel
Els C
EC
Nieuwhof
Eveline M
EM
Hop
Wim C J
WC
Affourtit
Marjo J
MJ
Smit
Frank J
FJ
Vaessen-Verberne
Anja A P H
AA
Versteegh
Florens G A
FG
de Jongste
Johan C
JC
Merkus
Peter J F M
PJ
D000280:Administration, Inhalation; D000730:Androstadienes / Q000008:administration & dosage*; D001993:Bronchodilator Agents / Q000008:administration & dosage*; D002675:Child, Preschool; D003876:Dermatitis, Atopic / Q000150:complications / Q000188:drug therapy; D004311:Double-Blind Method; D004485:Eczema / Q000150:complications / Q000188:drug therapy; D005260:Female; D000068298:Fluticasone; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D007073:Immunoglobulin E / Q000097:blood; D007223:Infant; D008168:Lung / Q000187:drug effects* / Q000503:physiopathology*; D008297:Male; D012129:Respiratory Function Tests / Q000379:methods; D012135:Respiratory Sounds / Q000187:drug effects* / Q000209:etiology / Q000276:immunology; D016896:Treatment Outcome
D000730:Androstadienes; D001993:Bronchodilator Agents; D007073:Immunoglobulin E; D000068298:Fluticasone