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Fig. 1 | Respiratory Research

Fig. 1

From: Development of methodology for assessing steroid-tapering in clinical trials for biologics in asthma

Fig. 1

OCS-sparing schedules during the OCS dosing reduction period (A) and overall trial design (B). In the key single-center study, patients with a baseline OCS dose ≥ 15 mg/day were not permitted to reduce their dose below 5 mg/day and patients with baseline 10– < 15 mg/day were not permitted to reduce their dose below 2.5 mg/day; only patients with a baseline dose < 10 mg/day were permitted to reduce to 0 mg/day. In SIRIUS, patients with an optimized OCS dose of ≥ 25 mg/day were not permitted to reduce their dose to 0 mg/day (not permitted below 2.5 mg/day). In ZONDA, patients with an optimized dose of between 20 and 30 mg/day were not permitted to reduce their dose below 5 mg/day and patients with an optimized dose of 17.5 or 15 mg/day were held temporarily at 5 mg/day for at least 8 weeks before continuing OCS dose reductions; only patients who were receiving an optimized dose of ≤ 12.5 mg/day could reduce their dose to 0 mg/day. In VENTURE, patients with an optimized OCS dose of ≥ 35 mg/day were not permitted to reduce their dose below 2.5 mg/day; only patients receiving an optimized dose < 35 mg/day could reduce their dose to 0 mg/day. Further information detailing the criteria for not reducing OCS dose for each study can be found in the Additional file 1. Patients in ZONDA with documented failures of OCS dose reduction within 6 months prior to enrollment were not required to proceed through the OCS dose optimization phase (Additional file 1). *Starting doses of 12.5 mg/day had an initial reduction of 2.5 mg/day (to 10 mg/day) followed by a reduction of 5 mg/day (to 5 mg/day); variable duration with no minimum or maximum limits, depending on individual baseline OCS dose; no further changes in OCS dose were permitted during this period. OCS oral corticosteroid

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