Long-Term Inhaled Corticosteroids in Preschool Children at High Risk for Asthma
Theresa W. Guilbert, M.D., Wayne J. Morgan, M.D., Robert S. Zeiger, M.D., Ph.D., David T. Mauger, Ph.D., Susan J. Boehmer, M.A., Stanley J. Szefler, M.D., Ph.D., Leonard B. Bacharier, M.D., Robert F. Lemanske, Jr., M.D., Robert C. Strunk, M.D., David B. Allen, M.D., Gordon R. Bloomberg, M.D., Gregory Heldt, M.D., Marzena Krawiec, M.D., Gary Larsen, M.D., Andrew H. Liu, M.D., Vernon M. Chinchilli, Ph.D., Christine A. Sorkness, Pharm.D., Lynn M. Taussig, M.D., and Fernando D. Martinez, M.D.
Background It is unknown whether inhaled corticosteroids canmodify the subsequent development of asthma in preschool childrenat high risk for asthma.
Methods We randomly assigned 285 participants two or three yearsof age with a positive asthma predictive index to treatmentwith fluticasone propionate (at a dose of 88 µg twicedaily) or masked placebo for two years, followed by a one-yearperiod without study medication. The primary outcome was theproportion of episode-free days during the observation year.
Results During the observation year, no significant differenceswere seen between the two groups in the proportion of episode-freedays, the number of exacerbations, or lung function. Duringthe treatment period, as compared with placebo use, use of theinhaled corticosteroid was associated with a greater proportionof episode-free days (P=0.006) and a lower rate of exacerbations(P<0.001) and of supplementary use of controller medication(P<0.001). In the inhaled-corticosteroid group, as comparedwith the placebo group, the mean increase in height was 1.1cm less at 24 months (P<0.001), but by the end of the trial,the height increase was 0.7 cm less (P=0.008). During treatment,the inhaled corticosteroid reduced symptoms and exacerbationsbut slowed growth, albeit temporarily and not progressively.
Conclusions In preschool children at high risk for asthma, twoyears of inhaled-corticosteroid therapy did not change the developmentof asthma symptoms or lung function during a third, treatment-freeyear. These findings do not provide support for a subsequentdisease-modifying effect of inhaled corticosteroids after thetreatment is discontinued. (ClinicalTrials.gov number, NCT00272441
[ClinicalTrials.gov]
.)
Source Information
From the Arizona Respiratory Center, University of Arizona, Tucson (T.W.G., W.J.M., F.D.M.); Kaiser Permanente, San Diego, Calif. (R.S.Z.); the University of California–San Diego, San Diego (R.S.Z., G.H.); Pennsylvania State University, Hershey (D.T.M., S.J.B., V.M.C.); National Jewish Medical and Research Center, Denver (S.J.S., G.L., A.H.L., L.M.T.); Washington University, St. Louis (L.B.B., R.C.S., G.R.B.); and the University of Wisconsin, Madison (R.F.L., D.B.A., M.K., C.A.S.).
Address reprint requests to Dr. Guilbert at the Division of Pediatric Pulmonary Medicine, Arizona Respiratory Center, University of Arizona, 1501 N. Campbell Ave., P.O. Box 245073, Tucson, AZ 85724, or at guilbert{at}arc.arizona.edu.
Inhaled Corticosteroids and Children
Köhler D., Haidl P., Dellweg D., Bont L., Kimpen J. L.L., Ermers M. J.J., Baraldi E., Filippone M., Guilbert T., Martinez F. D., Szefler S. J., the Childhood Asthma Research and Education (CARE) Network Steering Committee , Bisgaard H., Gold D. R., Fuhlbrigge A. L.
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N Engl J Med 2006;
355:624-626, Aug 10, 2006.
Correspondence
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