Table 2.
Summary of select clinical trials for systemic corticosteroids compared with placebo
| Trial | Design | Intervention | Baseline patient characteristics | Primary outcomes/results | Selected secondary outcomes |
|---|---|---|---|---|---|
| Albert et al26 | R, DB, PC n=44 | IV methylprednisolone 0.5 mg/kg every 6 hours for 72 hours versus placebo | Mean age 62 years FEV1 =0.72 L | • Change in FEV1 significantly higher for methylprednisolone versus placebo (220 mL, P<0.001) | No observed differences in FVC, arterial pH, or PaCO2 |
| Thompson et al17 | R, DB, PC n=27 | Oral prednisone taper: mg ×3 days, 40 mg ×3 days, 20 mg ×3 days versus placebo | Mean age 67.8 years FEV1 =1.3 L | • Change in PaO2 versus placebo (1.12 mmHg/day versus −0.03 mmHg/day, P=0.002) • Change in A–aD versus placebo O2 (−1.16 mmHg/day versus −0.03 mmHg/day, P=0.04) • FEV1 0.05 L/day versus 0 L/day (P=0.006) • PEF 0.15 L/s/day versus 0.04 L/s/day (P=0.009) |
|
| Davies et al16 | R, DB, PC n=56 | Oral prednisolone 30 mg once daily ×14 days versus placebo | Mean age 67 years FEV1 =0.59 L | • Predicted FEV1 increased from 28.2% to 41.5% in the corticosteroid group (P<0.001) | Hospital stays were shorter in the corticosteroid group |
| Niewoehner et al30 | R, DB, PC n=271 | Oral glucocorticoid for 2 weeks versus 8 weeks versus placebo | Mean age 67.6 years FEV1 =0.77 L | • Rate of treatment failure glucocorticoids versus placebo at 30 days (23% versus 33%, P=0.04) and 90 days (37% versus 48%, P=0.04) | Systemic steroids (in both groups) associated with a shorter initial hospital stay (8.5 days versus 9.7 days for placebo, P=0.03) |
| Aaron et al31 | R, DB, PC n=147 | Oral prednisone 40 mg once daily versus placebo | Mean age 69 years FEV1 =1 L | • Rate of relapse at 30 days was lower in the prednisone group versus placebo (27% versus 43%, P=0.05) | Change in Postbronchodilator FEV1 from day 1 to day 10 prednisone versus placebo (34% versus 15%, P=0.007) |
Abbreviations: A–aDO2, alveolar–arterial oxygen gradient; COPD, chronic obstructive pulmonary disease; DB, double blind; FEV1, forced expiratory volume in 1 second; IV, intravenous; PaO2, arterial PO2; PC, placebo controlled; PEF, peak expiratory flow; R, randomized; s, second.