Multicenter randomized controlled trial of withdrawal of inhaled corticosteroids in XXXX .

@entity1 @entity796 @entity55 @entity228 @entity5023 @entity1577
RATIONALE: @entity55 and injury is critical in @entity1577 . An ideal antiinflammatory agent has not been identified but inhaled corticosteroids are widely used despite lack of evidence. OBJECTIVES: To test the safety of withdrawal of inhaled corticosteroids with the hypothesis this would not be associated with an earlier onset of acute chest exacerbations. METHODS: Multicenter randomized double-blind placebo-controlled trial in 18 pediatric and adult UK centers. Eligibility criteria included age>6.0 yr, FEV1>or=40% predicted, and @entity228 use>3 mo. During the 2-mo run-in period, all @entity1 received @entity5023 ; they then took either @entity5023 or placebo for 6 mo. MEASUREMENTS AND MAIN RESULTS: @entity5023 group: n=84, median age 14.6 yr, mean (SD) FEV1 76% (18); placebo group: n=87, median age 15.8 yr, mean (SD) FEV1 76% (18). There was no difference in time to first exacerbation (primary outcome) with hazard ratio (95% confidence interval) of 1.07 (0.68 to 1.70) for @entity5023 versus placebo. There was no effect of age, atopy, @entity228 dose, FEV1, or @entity796 status. There was no change in lung function or differences in antibiotic or rescue bronchodilator use. Fewer @entity1 in the @entity5023 group withdrew from the study due to lung-related adverse events (9 vs. 15%); with a relative risk (95% confidence interval) of 0.59 (0.23-1.48) @entity5023 versus placebo. CONCLUSIONS: In this study population (applicable to 40% of @entity1 with @entity1577 in the UK), it appears safe to consider stopping inhaled corticosteroids. Potential advantages will be to reduce the drug burden on @entity1 , reduce adverse effects, and make financial savings.
