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Table 1 Characteristics of the included studies: summary

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 Î¼g & Olodaterol 5 Î¼g (1135)

Tiotropium 18 Î¼g & 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 Î¼g & Olodaterol 5 Î¼g

Tiotropium 5 Î¼g & Olodaterol 5 Î¼g

[FDC via Respimat®, once-daily × 6 wk]

Salmeterol & Fluticasone 50/250 Î¼g

Salmeterol & Fluticasone 50/500 Î¼g

(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 Î¼g & Olodaterol 5 Î¼g

Tiotropium 5 Î¼g & Olodaterol 5 Î¼g

[FDC via Respimat®, once-daily × 6 wk]

Tiotropium 5 Î¼g

Olodaterol 5 Î¼g

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 Î¼g & Olodaterol 5 Î¼g (404)

Tiotropium 5 Î¼g & Olodaterol 5 Î¼g (406)

[FDC via Respimat®, once-daily × 12 wk]

Tiotropium 5 Î¼g (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 Î¼g & Olodaterol 5 Î¼g (1030)

Tiotropium 5 Î¼g & Olodaterol 5 Î¼g (1029)

[FDC via Respimat®, once-daily × 52 wk]

Tiotropium 2.5 Î¼g (1032)

Tiotropium 5 Î¼g (1033)

Olodaterol 5 Î¼g (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 Î¼g & Olodaterol 5 Î¼g

Tiotropium 5 Î¼g & Olodaterol 5 Î¼g

[FDC via Respimat®, once-daily × 6 wk]

Tiotropium 2.5 Î¼g

Tiotropium 5 Î¼g

Olodaterol 5 Î¼g

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