期刊
JOURNAL OF ALLERGY AND CLINICAL IMMUNOLOGY
卷 128, 期 5, 页码 956-U386出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaci.2011.06.027
关键词
Asthma Predictive Index; atopy; clinical trials; early childhood asthma; fluticasone; inhaled corticosteroids; intermittent wheezing; linear growth; research network
资金
- National Heart, Lung, and Blood Institute [HL071742, HL004519-04, 5U10HL064287, 5U10HL064288, 5U10HL064295, 5U10HL064307, 5U10HL064305, 5U10HL064313]
- National Institutes of Health (NIH) [1 UL1 RR025780]
- National Center for Research Resources (NCRR)
- Altus Pharmaceuticals
- Inspire Pharmaceuticals
- National Institutes of Health (NIH)
- Aerocrine
- Genentech
- GlaxoSmithKline
- Merck and Co
- AstraZeneca
- TEVA Pharmaceuticals
- Medical Research and Education (Detroit)
- Children's Hospital of Minnesota
- Toronto Allergy Society
- Beaumont Hospital (Detroit)
- University of Illinois
- Canadian Society of Allergy and Clinical Immunology, New York Presbyterian
- American College of Allergy, Asthma Immunology
- American Academy of Allergy, Asthma Immunology
- National Institute of Allergy and Infectious Diseases (NIAID)
- National Institute of Environmental Health Sciences/Environmental Protection Agency
- NIH/National Heart, Lung, and Blood Institute (NHLBI)
- NIH/NHLBI
- Schering-Plough
- Compleware/Sandoz
- MedImmune
- Pfizer
- NIH
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 mu g/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 mu g/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. (J Allergy Clin Immunol 2011;128: 956-63.)
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