From: Efficacy and safety of tiotropium and olodaterol in COPD: a systematic review and meta-analysis
Study, Year | Intervention (Participants) | Design, Follow up | Multicenter/ Double blind | Baseline characteristics | Risk of Bias |
---|---|---|---|---|---|
ANHELTO 1 & 2 2014 | Tiotropium 18 μg & Olodaterol 5 μg (1135) Tiotropium 18 μg & Placebo (1136) Administered in two separate inhalers (Respimat® inhaler for Olodaterol and Spiriva Handihaler® for Tiotropium), once-daily × 12 wk | Parallel RCT, 15 weeks | ✓/✓ | Mean(SD) age – 51.7(9) Male – 51.7% Ex-smokers – 51% GOLD 2–58.9%, GOLD 3–41.1% | Low |
ENERGITO 2016 | Tiotropium 2.5 μg & Olodaterol 5 μg Tiotropium 5 μg & Olodaterol 5 μg [FDC via Respimat®, once-daily × 6 wk] Salmeterol & Fluticasone 50/250 μg Salmeterol & Fluticasone 50/500 μg (N = 229 × 4) | Crossover RCT, Participants completed 4/4 arms >6 weeks | ✓/✓ | Mean(SD) age - 63.6(7.6) Male – 64.6% Ex-smokers – 55.5% GOLD 2–72.1%, GOLD 3–27.9% | Low |
MORACTO 1 & 2 2015 | Tiotropium 2.5 μg & Olodaterol 5 μg Tiotropium 5 μg & Olodaterol 5 μg [FDC via Respimat®, once-daily × 6 wk] Tiotropium 5 μg Olodaterol 5 μg Placebo (N = 586 × 4) | Crossover RCT, Participants completed 4/5 arms, 6 weeks | ✓/✓ | Mean(SD) age – 61.7(7.7) Male – 71.2% Ex-smokers – 60.9% GOLD 2–71%, GOLD 3–28% | Low |
OTEMTO 1 & 2 2015 | Tiotropium 2.5 μg & Olodaterol 5 μg (404) Tiotropium 5 μg & Olodaterol 5 μg (406) [FDC via Respimat®, once-daily × 12 wk] Tiotropium 5 μg (407) Placebo (406) | Parallel RCT, 15 weeks | ✓/✓ | Mean(SD) age – 64.7(8.4) Male – 60.9% Ex-smokers – 52.9% GOLD 2–64.4%, GOLD 3–35.6% | Low |
TONADO 1 & 2 2015 | Tiotropium 2.5 μg & Olodaterol 5 μg (1030) Tiotropium 5 μg & Olodaterol 5 μg (1029) [FDC via Respimat®, once-daily × 52 wk] Tiotropium 2.5 μg (1032) Tiotropium 5 μg (1033) Olodaterol 5 μg (1038) | Parallel RCT, 52 weeks | ✓/✓ | Mean(SD) age - 646(8.3) Male – 73.3% Ex-smokers – 63.% GOLD 2–50.1%, GOLD 3,4–49.9% | Low |
VIVACITO 2015 | Tiotropium 2.5 μg & Olodaterol 5 μg Tiotropium 5 μg & Olodaterol 5 μg [FDC via Respimat®, once-daily × 6 wk] Tiotropium 2.5 μg Tiotropium 5 μg Olodaterol 5 μg Placebo (N = 259 × 6) | Crossover RCT, Participants completed 4/6 arms, 6 weeks | ✓/✓ | Mean(SD) age - 61.1(7.7) Male - 58.9% Ex-smokers - 37.4% GOLD 2–63.5%, GOLD 3,4–36.5% | Low |