TY - JOUR T1 - Short term glucocorticoid therapy in acute exacerbations of chronic obstructive pulmonary disease: “REDUCE*”, a non-inferiority multicenter trial. (*<span class="underline">Red</span>uction in the <span class="underline">U</span>se of <span class="underline">C</span>orticosteroids in <span class="underline">E</span>xacerbated COPD; ISRCTN19646069) JF - European Respiratory Journal JO - Eur Respir J VL - 40 IS - Suppl 56 SP - 4293 AU - Jörg D. Leuppi AU - Philipp Schütz AU - Roland Bingisser AU - Matthias Briel AU - Tilman Drescher AU - Ursula Dürring AU - Christoph Henzen AU - Yolanda Leibbrandt AU - Sabrina Maier AU - David Miedinger AU - Beat Müller AU - Andreas Scherr AU - Christian Schindler AU - Rolf Stöckli AU - Sebastian Viatte AU - Christophe von Garnier AU - Michael Tamm AU - Jonas Rutishauser Y1 - 2012/09/01 UR - http://erj.ersjournals.com/content/40/Suppl_56/4293.abstract N2 - Background: The optimal dose and duration of systemic glucocorticoid therapy for acute exacerbations of COPD (AECOPD) is unknown. In this trial, we aimed to demonstrate non-inferiority of 5-days vs 14-days of systemic glucocorticoids with respect to COPD exacerbation.Methods: Patients admitted to hospital with AECOPD were randomized to receive 40mg of prednisone-equivalent daily for either 5 or 14 days in a placebo-controlled fashion. Follow-up was 180 days. The primary endpoint was time to next exacerbation.Results: Of 721 evaluated patients, 327 underwent randomization, and 304 completed the study. Mean age was 63.9 ±23.2 years; mean FEV1%predicted 31.5 ±14.3% and 60.8% were male. Exacerbations occurred in 36.8% and 38.4% of patients in the 5 day and 14 day treatment arms, respectively (p=0.81). Time to exacerbation did not differ between groups in the intention-to-treat and per-protocol analyses (hazard ratios for the short treatment arm, 0.92 [95%-CI, 0.64 to 1.34; p=0.67] and 0.91 [95%-CI, 0.63 to 1.32; p=0.62], respectively); nor did time to death or the combined endpoint of exacerbation and/or death, with both hazard ratios for the short treatment arm being &lt;1 as well. With respect to the primary outcome, short treatment was not inferior to conventional treatment, since the 95%-confidence intervals did not include the predefined non-inferiority threshold of 1.515.Conclusion: In AECOPD, 5-day treatment with systemic glucocorticoids is non-inferior to 14-day treatment with regard to re-exacerbation during 6 months of follow-up. ER -