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Benefits of budesonide or nedocromil for mild to moderate asthma in children were not sustained after discontinuation

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Study design


randomised controlled trial (RCT).





Study question


8 clinical centres in Canada and the USA.


1041 patients 5–12 years of age {mean age 9 y, 60% boys}‡ who had chronic mild to moderate asthma and airway responsiveness to methacholine. Exclusion criteria included {other pulmonary disease or ventilatory defect, severe chronic sinusitis or nasal polyposis, use of >4 sprays/day of nasal steroids (except beclometasone), and treatment for gastro-oesophageal reflux}.†


after a mean 4.3 years of treatment, patients stopped continuous treatment with budesonide Turbuhaler, 200 μg twice daily {n = 311}‡; nedocromil, 8 mg twice daily {n = 312]‡; or placebo matching budesonide {n = 208}‡ or nedocromil {n = 210}‡.


FEV1 % of predicted post-bronchodilator. Secondary outcomes included FEV1 % of predicted pre-bronchodilator use, prednisone courses, urgent care visits, and adverse effects (height). {The study had 90% power …

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  • Source of funding: National Heart, Lung, and Blood Institute and National Center for Research Resources.