Background We hypothesized that asthma is preceded by a stageof recurrent episodes of wheezing during the first years oflife and that inhaled corticosteroid therapy during symptomaticepisodes in this early phase may delay progression to persistentwheezing.
Methods We assigned one-month-old infants to treatment withtwo-week courses of inhaled budesonide (400 µg per day)or placebo, initiated after a three-day episode of wheezing,in this single-center, randomized, double-blind, prospectivestudy of three years' duration. The primary outcome was thenumber of symptom-free days; key secondary outcomes were thetime to discontinuation due to persistent wheezing and safety,as evaluated by height and bone mineral density at the end ofthe study.
Results We enrolled 411 infants and randomly assigned 294 toreceive budesonide at a first episode of wheezing. The proportionof symptom-free days was 83 percent in the budesonide groupand 82 percent in the placebo group (absolute difference, 1percent; 95 percent confidence interval, –4.8 to 6.9 percent).Twenty-four percent of children in the budesonide group hadpersistent wheezing, as compared with 21 percent in the placebogroup (hazard ratio, 1.22; 95 percent confidence interval, 0.71to 2.13) — a finding that was unaffected by the presenceor absence of atopic dermatitis. The mean duration of the acuteepisodes was 10 days in both groups and was independent of respiratoryviral status. Height and bone mineral density were not affectedby treatment.
Conclusions Intermittent inhaled corticosteroid therapy hadno effect on the progression from episodic to persistent wheezingand no short-term benefit during episodes of wheezing in thefirst three years of life. (ClinicalTrials.gov number, NCT00234390
[ClinicalTrials.gov]
.)
Source Information
From the Danish Pediatric Asthma Center, Copenhagen University Hospital, Gentofte, Copenhagen.
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.
Extract |
Full Text |
PDF
N Engl J Med 2006;
355:624-626, Aug 10, 2006.
Correspondence
This article has been cited by other articles:
Baumer, J H
(2008). Recent asthma updates in the USA and UK. EDUCATION AND PRACTICE
93: 66-68
[Full Text]
Bush, A.
(2008). Update in Pediatric Lung Disease 2007. Am. J. Respir. Crit. Care Med.
177: 686-695
[Full Text]
Bateman, E. D., Hurd, S. S., Barnes, P. J., Bousquet, J., Drazen, J. M., FitzGerald, M., Gibson, P., Ohta, K., O'Byrne, P., Pedersen, S. E., Pizzichini, E., Sullivan, S. D., Wenzel, S. E., Zar, H. J.
(2008). Global strategy for asthma management and prevention: GINA executive summary. Eur Respir J
31: 143-178
[Abstract][Full Text]
Devulapalli, C S, Carlsen, K C L, Haland, G, Munthe-Kaas, M C, Pettersen, M, Mowinckel, P, Carlsen, K-H
(2008). Severity of obstructive airways disease by age 2 years predicts asthma at 10 years of age. Thorax
63: 8-13
[Abstract][Full Text]
Saglani, S., Payne, D. N., Zhu, J., Wang, Z., Nicholson, A. G., Bush, A., Jeffery, P. K.
(2007). Early Detection of Airway Wall Remodeling and Eosinophilic Inflammation in Preschool Wheezers. Am. J. Respir. Crit. Care Med.
176: 858-864
[Abstract][Full Text]
Bisgaard, H., Hermansen, M. N., Buchvald, F., Loland, L., Halkjaer, L. B., Bonnelykke, K., Brasholt, M., Heltberg, A., Vissing, N. H., Thorsen, S. V., Stage, M., Pipper, C. B.
(2007). Childhood Asthma after Bacterial Colonization of the Airway in Neonates. NEJM
357: 1487-1495
[Abstract][Full Text]
Townshend, J, Hails, S, Mckean, M
(2007). Management of asthma in children. BMJ
335: 253-257
[Full Text]
Moore, W. C., Peters, S. P.
(2007). Update in Asthma 2006. Am. J. Respir. Crit. Care Med.
175: 649-654
[Full Text]
de Jongste, J. C.
(2006). To Wheeze or Not to Wheeze: Prospective FENO-typing in Early Infancy. Am. J. Respir. Crit. Care Med.
174: 1281-1282
[Full Text]
Mazer, B.
(2006). 2 year inhaled corticosteroid therapy did not prevent asthma in high risk preschool children after treatment was discontinued. Evid. Based Med.
11: 174-174
[Full Text]
Proud, D., Chow, C.-W.
(2006). Role of Viral Infections in Asthma and Chronic Obstructive Pulmonary Disease. Am. J. Respir. Cell Mol. Bio.
35: 513-518
[Abstract][Full Text]
Kohler, 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), , Bisgaard, H., Gold, D. R., Fuhlbrigge, A. L.
(2006). Inhaled corticosteroids and children.. NEJM
355: 624-624
[Full Text]
Church, C
(2006). When should we use inhaled steroids in 'asthmatic' infants?. Thorax
61: 677-677
[Full Text]
(2006). Can Early Inhaled Steroids Modify the Course of Asthma in Children?. JWatch Pediatrics
2006: 6-6
[Full Text]
(2006). Can Inhaled Steroids Modify the Course of Asthma?. JWatch General
2006: 4-4
[Full Text]
Guilbert, T. W., Morgan, W. J., Zeiger, R. S., Mauger, D. T., Boehmer, S. J., Szefler, S. J., Bacharier, L. B., Lemanske, R. F. Jr., Strunk, R. C., Allen, D. B., Bloomberg, G. R., Heldt, G., Krawiec, M., Larsen, G., Liu, A. H., Chinchilli, V. M., Sorkness, C. A., Taussig, L. M., Martinez, F. D.
(2006). Long-term inhaled corticosteroids in preschool children at high risk for asthma.. NEJM
354: 1985-1997
[Abstract][Full Text]
Gold, D. R., Fuhlbrigge, A. L.
(2006). Inhaled corticosteroids for young children with wheezing.. NEJM
354: 2058-2060
[Full Text]
Previous
