Preemptive use of high-dose fluticasone for virus-induced wheezing in young children.
BACKGROUND
Although virus-induced wheezing is common in preschool-age children, optimal management remains elusive. We examined the efficacy and safety of preemptive treatment with high-dose fluticasone in reducing the severity of recurrent virus-induced wheezing in children.


METHODS
We randomly assigned 129 children who were 1 to 6 years of age to receive 750 microg of fluticasone propionate (ex-valve [manufacturer-measured] dose) or placebo twice daily, beginning at the onset of an upper respiratory tract infection and continuing for a maximum of 10 days, over a period of 6 to 12 months. The primary outcome was rescue oral corticosteroid use. Secondary outcomes included symptoms, use of beta(2)-agonists, acute care visits, hospitalizations, discontinuation of the study drug, change in growth and bone mineral density, basal cortisol level, and adverse events.


RESULTS
Over a median period of 40 weeks, 8% of upper respiratory tract infections in the fluticasone group led to treatment with rescue systemic corticosteroids, as compared with 18% in the placebo group (odds ratio, 0.49; 95% confidence interval [CI], 0.30 to 0.83). Children who were treated with fluticasone, as compared with those who were given placebo, had smaller mean (+/-SD) gains from baseline in height (6.23+/-2.62 cm [unadjusted value]; z score, -0.19 +/-0.42 vs. 6.56+/-2.90 cm [unadjusted value]; z score, 0.00+/-0.48; difference between groups in z score from baseline to end point, -0.24 [95% CI, -0.40 to -0.08]) and in weight (1.53+/-1.17 kg [unadjusted value]; z score, -0.15+/-0.48 vs. 2.17+/-1.79 kg [unadjusted value]; z score, 0.11+/-0.43; difference between groups in z score from baseline to end point, -0.26 [95% CI, -0.41 to -0.09]). There were no significant differences between the groups in basal cortisol level, bone mineral density, or adverse events.


CONCLUSIONS
In preschool-age children with moderate-to-severe virus-induced wheezing, preemptive treatment with high-dose fluticasone as compared with placebo reduced the use of rescue oral corticosteroids. Treatment with fluticasone was associated with a smaller gain in height and weight. Given the potential for overuse, this preventive approach should not be adopted in clinical practice until long-term adverse effects are clarified. (ClinicalTrials.gov number, NCT00238927.)
Ducharme
Francine M
FM
Applied Clinical Research Unit, Centre Hospitalier Universitaire Sainte-Justine, and the Department of Pediatrics, University of Montreal, Montreal, Quebec, Canada. francine.m.ducharme@umontreal.ca
Lemire
Chantal
C
Noya
Francisco J D
FJ
Davis
G Michael
GM
Alos
Nathalie
N
Leblond
Hélène
H
Savdie
Cheryl
C
Collet
Jean-Paul
JP
Khomenko
Lyudmyla
L
Rivard
Georges
G
Platt
Robert W
RW
D000280:Administration, Inhalation; D000730:Androstadienes / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000517:prevention & control*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D000068298:Fluticasone; D005938:Glucocorticoids / Q000008:administration & dosage*; D006128:Growth / Q000187:drug effects; D006801:Humans; D007223:Infant; D008297:Male; D012135:Respiratory Sounds / Q000187:drug effects* / Q000209:etiology; D012141:Respiratory Tract Infections / Q000150:complications / Q000453:epidemiology / Q000821:virology; D014777:Virus Diseases / Q000150:complications*
D000730:Androstadienes; D001993:Bronchodilator Agents; D005938:Glucocorticoids; D000068298:Fluticasone