Table 2.
Results in GOLD stage II COPD patients in randomised clinical trials
| Study | Treatment | GOLD stage II patients (n) | Results |
|---|---|---|---|
| Decramer M, et al. UPLIFT study [66] | Tiotropium vs. placebo | 2739 | - Lower rate of decline of mean postbronchodilator FEV1 - improvement in the SGRQ - increase in the time to first exacerbation |
| Beeh KM, et al. [61] | Tiotropium vs. placebo | 586 | - increment in trough FEV1 |
| Duser D, et al. Mistral study [68] | Tiotropium vs. placebo | 426 | - reduction in the number of exacerbations |
| Freeman D, et al. SPRUCE study [62] | Tiotropium | 185 | - improvement in trough FEV1 - reduction in the number of exacerbations |
| Singh D, et al. OTEMTO study [64] | Tiotropium/olodaterol vs. tiotropium or placebo | 1042 | - improvement in the trough FEV1 - improvement in symptoms and the SGRQ |
| Vincken W, et al. [88] | Tiotropium vs. ipratropium | 535 | - improvement in trough FEV1 - improvement in PEFR, salbutamol use, TDI, and SGRQ - reduction in the number of exacerbations |
| Casburi R, et al. [89] | Tiotropium vs. placebo | 921 | - improvement in trough FEV1 - reduction in dyspnoea - improvement in health status scores - reduction in the number of exacerbations |
| Jenkins C, et al. TORCH study [63] | SFC vs. placebo | 2156 | - reduction in the risk of death - improvements in FEV1 - reduction in the annual rate of exacerbations |
| Jones PW, et al. ISOLDE study [90] | Fluticasone propionate vs. placebo | 391 (mild) 359 (moderate-severe) |
- reduction in the number of exacerbations (less in mild disease) |
| Vestbo J, et al. SUMMIT study [77] | Fluticasone fuorate vs. placebo vs. vilanterol vs. combination therapy | 4135 vs 4121 vs 4118 | - reduction in the rate of decline in FEV1 - reduction in the rate of moderate and severe exacerbation |
| Vogelmeier CF, et al. CRYSTAL study [65] | Indacaterol/glycopyrronium vs. LABA/ICS vs. LABA or LAMA | 811 vs. 269 811 vs. 268 |
- greater improvement on trough FEV1 - greater improvement in dyspnoea - greater improvement in health status - lower rescue medication use |
| Wedzicha JA, et al. [69] | Indacaterol/glycopyrronium vs. SFC | 1680 vs. 1682 | - superiority in reducing annual rate of exacerbations - longer time to the first exacerbation |
FEV1 forced expiratory volume in one second, ICS inhaled corticosteroids, LABA long-acting β2-agonist, LAMA long-acting muscarinic antagonist, PEFR peak expiratory flow rate, SFC inhaled salmeterol plus fluticasone propionate, SGRQ St George’s Respiratory Questionnaire, TDI transition dyspnoea index