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Table 2 Results in GOLD stage II COPD patients in randomised clinical trials

From: What have we learned from observational studies and clinical trials of mild to moderate COPD?

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
  1. 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