Table 1 Studies included in systematic review
Author (year of publication) | RCT source | Subjects (n) | Gender (M/F) | Age range (years) | COPD severity | %pred FEV1a | BMI (kg/m2)b | Duration (years) | Relevant study objectives |
|---|---|---|---|---|---|---|---|---|---|
Celli (2008) [16] | TORCH | 5343 | 4080/1263 | 40–80 | Moderate-very severe (FEV1 ≤ 60%pred) | 44.7 (13.1) | 25.4 (5.2) | 3 | Effect of inhaled FP, and FP plus salmeterol on annualized rate of decline in post-bronchodilator FEV1, compared to placebo; prespecified subanalysis by BMI category |
Calverley (2018) [17] | SUMMIT | 15,457 | 11,559/3898 | 40–80 | Moderate (FEV1 50–70%pred) | 59.7 (6.1)c | 28.0 (6.0) | ≥3 | Effect of FF, VI, and FF plus VI on annualized rate of decline in post-bronchodilator FEV1, compared to placebo; prespecified subanalysis by BMI category |
Anzueto (2015) [20] | TIOSPIR | 1370 | 849/521 | ≥40 | Moderate-very severe (FEV1 ≤ 70%pred) | 47.5 (12.7)d | 25.9 (5.1)d | 2.3 | Effect of TIO Respimat versus TIO HandiHaler on safety outcomes, with prespecified non-inferiority spirometry substudy examining annualized rate of decline in trough FEV1; prespecified subanalysis by BMI category |
Tashkin (2008) [19] | UPLIFT | 4964 | 3757/1207 | ≥40 | Moderate-very severe (FEV1 ≤ 70%pred) | 48.6 (13.4) | NS | 4 | Effect of TIO HandiHaler on annualized rate of decline in pre- and post-study drug FEV1, compared to placebo; prespecified subanalysis by BMI category within each treatment group |
Tkacova (2016) [15] | LHS | 5887 | 3702/2185 | 35–60 | Mild-moderate (FEV1 55–90%pred) | 80e | 25.2e | 5 | Effect of AHR on annualized rate of decline in FEV1 (unspecified bronchodilator), examining baseline BMI as a covariate |