TY - JOUR
T1 - Growth of preschool children at high risk for asthma 2 years after discontinuation of fluticasone
AU - Guilbert, Theresa W.
AU - Mauger, David
AU - Allen, David B.
AU - Zeiger, Robert S.
AU - Lemanske, Robert F.
AU - Szefler, Stanley J.
AU - Strunk, Robert C.
AU - Bacharier, Leonard B.
AU - Covar, Ronina
AU - Sorkness, Christine A.
AU - Taussig, Lynn M.
AU - Martinez, Fernando D.
N1 - Funding Information:
Supported by grants HL071742, HL004519-04, 5U10HL064287, 5U10HL064288, 5U10HL064295, 5U10HL064307, 5U10HL064305, and 5U10HL064313 from the National Heart, Lung, and Blood Institute . This study was carried out in part in the General Clinical Research Centers at Washington University School of Medicine (M01 RR00036) and under Colorado CTSA grant 1 UL1 RR025780 from the National Institutes of Health (NIH) and National Center for Research Resources (NCRR) .
Funding Information:
Disclosure of potential conflict of interest: T. W. Guilbert has consulted for GlaxoSmithKline, AstraZeneca, MAP Pharmaceutical, Merck/Schering-Plough, and Genentech/Novartis; has designed and presented a CME-accredited series on respiratory syncytial virus disease for Peerpoint Medical Education Institute; and has received research support from Altus Pharmaceuticals, Inspire Pharmaceuticals, and the National Institutes of Health (NIH) . R. S. Zeiger has consulted for AstraZeneca, Aerocrine, Genentech, Novartis, Merck and Co, Schering-Plough, and MedImmune and has received research support through Kaiser Permanente or the Childhood Asthma Research and Education Network Clinical Trial from Aerocrine, Genentech, GlaxoSmithKline, Merck and Co, AstraZeneca, and TEVA Pharmaceuticals. R. F. Lemanske, Jr has given lectures for Merck, AstraZeneca, Doembecher Children's Hospital, Washington University, Medicus Group, Park Nicolet Institute, the LA Allergy Society, the Michigan Allergy/Asthma Society, the Medical College of Wisconsin, the Fund for Medical Research and Education (Detroit), Children's Hospital of Minnesota, the Toronto Allergy Society, Beaumont Hospital (Detroit), the University of Illinois, the Canadian Society of Allergy and Clinical Immunology, New York Presbyterian, the American College of Allergy, Asthma & Immunology, and the American Academy of Allergy, Asthma & Immunology; has consulted for AstraZeneca, Map Pharmaceuticals, Gray Consulting, Smith Research, Quintiles/Innovax, RC Horowitz & Co, International Meetings and Science, and Scienomics; has written for Up-to-Date; and has edited a textbook for Elsevier. S. J. Szefler has consulted for GlaxoSmithKline, Genentech, Merck, Boehringer-Ingelheim, Novartis, and Schering-Plough and has received research support from the National Institute of Allergy and Infectious Diseases (NIAID), GlaxoSmithKline, the National Institute of Environmental Health Sciences/Environmental Protection Agency, and the NIH/National Heart, Lung, and Blood Institute (NHLBI) . L. B. Bacharier has received honoraria from AstraZeneca; received honoraria and served on an advisory board for Genentech, GlaxoSmithKline, Merck, Schering-Plough, and Aerocrine; and received research support from the NIH/NHLBI . R. Covar has received research support from the NIH/NHLBI . C. A. Sorkness has served on advisory boards for GlaxoSmithKline, Schering-Plough, AstraZeneca, and Novartis and received research support from Schering-Plough and Compleware/Sandoz . F. D. Martinez has served on an advisory board for and received lecture fees from Merck; has consulted for GlaxoSmithKline and MedImmune; has received lecture fees from Pfizer; and has received research support from the NIH . The rest of the authors have declared that they have no conflict of interest.
PY - 2011/11
Y1 - 2011/11
N2 - Background: The effect on linear growth of daily long-term inhaled corticosteroid therapy in preschool-aged children with recurrent wheezing is controversial. Objective: We sought to determine the effect of daily inhaled corticosteroid given for 2 years on linear growth in preschool children with recurrent wheezing. Methods: Children aged 2 and 3 years with recurrent wheezing and positive modified Asthma Predictive Index scores were randomized to a 2-year treatment period of chlorofluorocarbon-delivered fluticasone propionate (176 μg/d) or masked placebo delivered through a valved chamber with a mask and then followed for 2 years off study medication. Height growth determined by means of stadiometry was compared between treatment groups. Results: In the study cohort as a whole, the fluticasone group did not have significantly less linear growth than the placebo group (change in height from baseline difference, -0.2 cm; 95% CI, -1.1 to 0.6) 2 years after discontinuation of study treatment. In post hoc analyses children 2 years old who weighed less than 15 kg at enrollment and were treated with fluticasone had less linear growth compared with those treated with placebo (change in height from baseline difference, -1.6 cm; 95% CI, -2.8 to -0.4; P =.009). Conclusion: Linear growth was not significantly different in high-risk preschool-aged children with recurrent wheezing treated with 176 μg/d chlorofluorocarbon-delivered fluticasone compared with placebo 2 years after fluticasone is discontinued. However, post hoc subgroup analyses revealed that children who are younger in age and of lesser weight relative to the entire study cohort had significantly less linear growth, possibly because of a higher relative fluticasone exposure.
AB - Background: The effect on linear growth of daily long-term inhaled corticosteroid therapy in preschool-aged children with recurrent wheezing is controversial. Objective: We sought to determine the effect of daily inhaled corticosteroid given for 2 years on linear growth in preschool children with recurrent wheezing. Methods: Children aged 2 and 3 years with recurrent wheezing and positive modified Asthma Predictive Index scores were randomized to a 2-year treatment period of chlorofluorocarbon-delivered fluticasone propionate (176 μg/d) or masked placebo delivered through a valved chamber with a mask and then followed for 2 years off study medication. Height growth determined by means of stadiometry was compared between treatment groups. Results: In the study cohort as a whole, the fluticasone group did not have significantly less linear growth than the placebo group (change in height from baseline difference, -0.2 cm; 95% CI, -1.1 to 0.6) 2 years after discontinuation of study treatment. In post hoc analyses children 2 years old who weighed less than 15 kg at enrollment and were treated with fluticasone had less linear growth compared with those treated with placebo (change in height from baseline difference, -1.6 cm; 95% CI, -2.8 to -0.4; P =.009). Conclusion: Linear growth was not significantly different in high-risk preschool-aged children with recurrent wheezing treated with 176 μg/d chlorofluorocarbon-delivered fluticasone compared with placebo 2 years after fluticasone is discontinued. However, post hoc subgroup analyses revealed that children who are younger in age and of lesser weight relative to the entire study cohort had significantly less linear growth, possibly because of a higher relative fluticasone exposure.
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U2 - 10.1016/j.jaci.2011.06.027
DO - 10.1016/j.jaci.2011.06.027
M3 - Article
C2 - 21820163
AN - SCOPUS:80055085153
SN - 0091-6749
VL - 128
SP - 956-963.e7
JO - Journal of Allergy and Clinical Immunology
JF - Journal of Allergy and Clinical Immunology
IS - 5
ER -