From: Development of methodology for assessing steroid-tapering in clinical trials for biologics in asthma
Study reference | Patient age (years) | Asthma phenotype | Receiving OCS at enrollment | Duration of continuous OCS use | OCS dose* range at baseline (mg/day) | Asthma diagnosis criteria† |
---|---|---|---|---|---|---|
Key single-center study [19] (NCT00292877) | 18–70 | Asthma with persistent sputum eosinophilia despite OCS | Yes | ≥ 4 weeks | 5–25 | • Variable airway obstruction‡ in the previous 8 years • Sputum eosinophil > 3% |
SIRIUS [20] (NCT01691508) | ≥ 12 | Severe eosinophilic asthma | Yes | ≥ 6 months Stable: for ≥ 1 month | 5–35 | • Peripheral blood eosinophil count ≥ 300 cells/µL in the 12 months prior to screening or ≥ 150 cells/µL during OCS dose optimization period • Airway obstruction§, reversibility║,¶, hyperresponsiveness** within 12 months or variability during OCS dose optimization period†† • Very high-dose ICS‡‡ plus ≥ 1 controller for ≥ 3 months |
ZONDA [21] (NCT02075255) | 18–75 | Severe eosinophilic asthma | Yes | ≥ 6 months | 7.5–40 | • Peripheral blood eosinophil count ≥ 150 cells/µL at enrollment • ≥ 1 exacerbation in the prior 12 months • Medium-to-high dose ICS§§ for ≥ 12 months • LABA for ≥ 12 months |
VENTURE [22] (NCT02528214) | ≥ 12 | OCS dependent severe asthma║║ | Yes | ≥ 6 months Stable: for ≥ 1 month | 5–35 | • No eosinophil count requirement • High-dose ICS¶¶ (stable: for ≥ 1 month) plus ≥ 1 controller for ≥ 3 months • Airway obstruction§, reversibility║ or hyperresponsiveness** within 12 months |
≥ 18 | Severe eosinophilic asthma | Yes | ≥ 3 months Stable: for ≥ 4 weeks | ≥ 5 | • Peripheral blood eosinophil count ≥ 150 cells/µL at enrollment or ≥ 300 cells/µL in the 12 months prior to enrollment • High-dose ICS¶¶ plus LABA for ≥ 6 months |