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Table 2 Eligibility criteria for OCS-sparing studies

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

PONENTE [23, 24] (NCT03557307)

 ≥ 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

  1. FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, ICS inhaled corticosteroid, LABA long-acting β2-agonist, OCS oral corticosteroid, PC20 provocative concentration of methacholine resulting in a 20% decrease in FEV1, PD20 provocative dose of methacholine resulting in a 20% decrease in FEV1
  2. *Prednisone or equivalent; prior to enrollment, unless otherwise stated; at least a 25% reduction in FEV1 at the time of exacerbation; §pre-bronchodilator FEV1 < 80% predicted in patients ≥ 18 years of age (in SIRIUS, patients 12–17 years of age had to have pre-bronchodilator FEV1 < 90% predicted or FEV1/FVC ratio < 0.8; In VENTURE, adolescents had to have pre-bronchodilator FEV1 ≤ 90% predicted); FEV1 ≥ 12% and 200 mL; or FEV1 ≥ 20% between two consecutive clinical visits (excluding exacerbations); **PC20 < 8 mg/mL or PD20 < 7.8 µmol; †† > 20% diurnal variability in peak flow for ≥ 3 days during OCS dose optimization; ‡‡ ≥ 880 µg/day fluticasone propionate (12–17 years of age ≥ 440 µg/day); §§ > 250 μg fluticasone dry powder formulation equivalents total daily dose; ║║based on the Global Initiative for Asthma (GINA) 2014 guidelines (a history of respiratory symptoms such as wheeze, shortness of breath, chest tightness and cough that vary over time and in intensity, together with variable expiratory airflow limitation); ¶¶fluticasone propionate at a total daily dose of > 500 μg or equipotent equivalent