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Published ahead of print on March 23, 2006, doi:10.1164/rccm.200511-1808OC

Am. J. Respir. Crit. Care Med., Volume 173, Number 12, June 2006, 1356-1362

A more recent version of this article appeared on June 15, 2006
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Submitted on November 25, 2005
Accepted on March 23, 2006

Multicenter Randomized Controlled Trial of Withdrawal of Inhaled Corticosteroids in Cystic Fibrosis

Ian M Balfour-Lynn1*, Belinda Lees2, Pippa Hall1, Gillian Phillips1, Mohammed Khan2, Marcus Flather3, and J Stuart Elborn4

1 Department of Paediatric Respiratory Medicine, Royal Brompton Hospital, London, United Kingdom, 2 Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London, United Kingdom; National Heart and Lung Institute, Imperial College, London, United Kingdom, 3 Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London, United Kingdom, 4 Adult Cystic Fibrosis Unit, Belfast City Hospital, Belfast, United Kingdom

* To whom correspondence should be addressed. E-mail: i.balfourlynn{at}ic.ac.uk.

Rationale: Lung inflammation and injury is critical in cystic fibrosis. 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 wouldn't 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[[rad]]0 years, FEV1 ≥40% predicted, and corticosteroid use >3 months. During the 2-month run-in period, all patients received fluticasone; they then took either fluticasone or placebo for 6 months. Measurements and main results: Fluticasone group: n=84, median age 14[[rad]]6 years, mean (SD) FEV1 76% (18); placebo group: n=87, median age 15[[rad]]8 years, mean (SD) FEV1 76% (18). There was no difference in time to 1st exacerbation (primary outcome) with hazard ratio (95% CI) of 1[[rad]]07 (0[[rad]]68 to 1[[rad]]70) for fluticasone vs placebo. There was no effect of age, atopy, corticosteroid dose, FEV1, and P. aeruginosa status. There was no change in lung function, or differences in antibiotic or rescue bronchodilator use. Fewer patients in the fluticasone group withdrew from the study due to lung-related adverse events (9% vs 15%); with a relative risk (95% CI) of 0[[rad]]59 (0[[rad]]23-1[[rad]]48) fluticasone vs placebo. Conclusions: In this study population (applicable to 40% UK cystic fibrosis patients), it appears safe to consider stopping inhaled corticosteroids. Potential advantages will be to reduce the drug burden on patients, reduce adverse effects, and make financial savings.
Key words: Lung diseases; inhaled corticosteroids; anti-inflammatory therapy




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