Table 1 Summary of included RCT studies
Author | Study name or trial number | Population size | Mean age (SD) | % Females | Common inclusion criteria | Common exclusion criteria |
|---|---|---|---|---|---|---|
Hoshino [40] | – | 30 | 73.4 | 6.7 | FEV1% predicted < 70 | Current maintenance therapies, current asthma, CVD |
Manoharan [41] | – | 13 | 69 | 23.1 | FEV1% predicted 30–80, current ICS/LABA use | Moderate ECOPD within 1 month or severe ECOPD within 3 months of inclusion |
Lee [42] | NCT01397890 | 578 | 66.8 | 4.3 | FEV1% predicted < 50, at least 1 moderate ECOPD in year prior to inclusion | Any severe ECOPD in month prior, ICS or OCS use 1 month prior to inclusion, history of asthma, history of CVD |
Singh [16] | TRILOGY | 1368 | 63.6 | 24.5 | FEV1% predicted < 50, at least 1 moderate ECOPD in year prior to inclusion, CAT score ≥ 10, ICS/LABA, ICS/LAMA, LABA/LAMA or LAMA prescribed 2 months prior to inclusion | Any severe ECOPD in month prior to inclusion, current asthma and history of CVD |
Vestbo [17] | TRINITY | 2691 | 63.0 | 24 | FEV1% predicted < 50, at least 1 moderate ECOPD in year prior to inclusion, CAT score ≥ 10, ICS/LABA, ICS/LAMA, LABA/LAMA or LAMA prescribed 2 months prior to inclusion | ECPOD 4 weeks prior to inclusion, on triple therapy 2 months prior to inclusion, current asthma and history of CVD |
Sousa [43] | NCT02257372 | 236 | 64.2 | 33 | FEV1% predicted < 70, current ICS/LABA use | ECOPD treated with antibiotics or oral corticosteroids within 6 weeks of inclusion, LAMA use within 1 week or LABA, LAMA/LABA use with 2 weeks of inclusion, current asthma, history of CVD |
Lipson [18] | FULFIL | 1810 | 63.9 | 26 | FEV1% predicted < 50% or FEV1% predicted 50–80% with at least 2 moderate or 1 severe ECOPD in the year prior to inclusion, CAT score ≥ 10, current maintenance therapy | Current asthma |
Lipson [19] | IMPACT | 10,355 | 65.3 | 34 | FEV1% predicted < 50% or FEV1% predicted 50–80% with at least 2 moderate or 1 severe ECOPD in the year prior to inclusion, CAT score ≥ 10, current maintenance therapy and ICS in last month | Current asthma |
Ferguson [20] | KRONOS | 1896 | 65.3 | 28.4 | FEV1% predicted 25–80, CAT score ≥ 10, maintenance therapy (no monotherapy) 6 weeks prior to inclusion | At least 1 moderate ECOPD 6 weeks prior to inclusion or 1 severe ECOPD within 3 months of inclusion, current asthma |
Dean [21] | TRIFLOW | 22 | 64 | 59.1 | FEV1% predicted 30–80, current ICS (dual or triple) | Moderate COPD within 2 months or a severe ECOPD within one year of inclusion |
Ferguson [20] | NCT03478683 NCT03478696; two replicate studies | 728 | 65.2 | 48.3 | FEV1% predicted < 50% or FEV1% predicted 50–80% with at least 2 moderate or 1 severe ECOPD in the year prior to inclusion, maintenance therapy for more than 3 months prior to inclusion, CAT ≥ 10 | Current asthma, history of CVD |
Rabe [22] | ETHOS | 8509 | 64.7 | 40.3 | FEV1% predicted 25–65%, 1 ECOPD in year prior to inclusion if FEV1% predicted < 50% or 2 moderate or 1 severe if FEV1% predicted > 50%, CAT ≥ 10, at least 1 maintenance therapies in the month prior to inclusion | Current asthma |
Salvi [28] | CTRI/2019/01/017156 | 396 | 61.1 | 4.9 | FEV1% predicted 30–80, at least 2 ECOPD in year prior to inclusion | A moderate ECOPD 6 weeks prior or 1 severe ECOPD 3 months prior to inclusion, current asthma |
Van den Berge [44] | NCT03836677 | 23 | 64.9 | 21.7 | FEV1% predicted 30–80, bronchodilator use 3 months prior to inclusion | Moderate ECOPD within 3 months of inclusion, ICS use in 3 months prior to inclusion, current asthma |
Zheng [23] | TRIVERSYTI | 708 | 66 | 95.3 | FEV1% predicted < 50, at least one ECOPD year prior to inclusion, dual maintenance therapy 2 months prior to inclusion | ECOPD in month prior to inclusion, current asthma |
Bansal [45] | NCT03474081 | 800 | 66.2 | 32 | FEV1% predicted 30–80, 2 moderate or 1 severe ECOPD in last year prior to inclusion if FEV1% predicted is 50–80%, CAT score ≥ 10, use of tiotropium in month prior to inclusion | Any ECOPD within 14 days of inclusion, no oral corticosteroids use in month prior to inclusion, current asthma |
Saito [46] | NCT01751113 | 53 | 67.3 | 2 | FEV1% predicted 30–75 | Severe ECOPD in year prior to inclusion, oral corticosteroids use in month prior to inclusion, current asthma |
Betsuyaku [47] | COSMOS-J | Protocol | FEV1% predicted 30–80 | Oral corticosteroids use month prior to inclusion, current asthma | ||
Papi [48] | TRIBUTE | 1532 | 64.5 | 28 | FEV1% predicted < 50, at least 1 ECOPD in the year prior to inclusion, CAT score ≥ 10, use of dual maintenance therapies 2 months prior to inclusion | Current asthma, history of CVD |
Bremner [49] | NCT02729051 | 1055 | 66.3 | 26 | FEV1% predicted < 50% or FEV1% predicted 50–80% with at least 2 moderate or 1 severe ECOPD in the year prior to inclusion, CAT score ≥ 10 | Any ECOPD within 2 weeks of inclusion, asthma, history of CVD |
Singh [16] | TRIDENT | 178 | 62.7 | 33.1 | FEV1% predicted 30–60, current ICS/LABA use prior to inclusion | Moderate ECOPD month prior to a severe ECOPD 3 months prior to inclusion, current asthma, history of CVD |
Siler [50] | NCT01957163 &  NCT02119286 : two replicate trials | 619 | 63.7 | 64.3 | FEV1% predicted ≤ 70 | Severe ECOPD 3 months prior to inclusion, current asthma, history of CVD |
Van der Palen [51] | NCT0298218 | 70 | 65 | 48 | Fixed ICS/LABA therapy 4 weeks prior to inclusion | Current asthma |
Worsley [25] | INTREPID | Protocol | At least 1 ECOPD 3 years prior to inclusion, CAT score ≥ 10, use of maintenance therapies within 4 months of inclusion | ECOPD 2 weeks prior to inclusion | ||
Clinical trials.gov | DARwiIN | Protocol | FEV1% predicted ≤ 60, at least 1 ECOPD within 1 year prior to inclusion, CAT score ≥ 10, use of ICS/LABA within 8 weeks of inclusion | Any ECOPD within 1 month of inclusion, current asthma, history of CVD | ||
Clinical trials.gov | AIRWISE | Protocol | Current use of ICS, LABA, ICS/LABA prior to inclusion | Use of LABA/LAMA prior to inclusion, current asthma | ||