Asthma: BT | | | | |
AIR [4] | BT: 56; control: 56 | Moderate/severe asthma, worsening control on LABA withdrawal, FEV1 60–85% | Usual care | Frequency of mild exacerbations at 3, 6, 12 months |
Primary end-point results: change in frequency per subject per week from baseline: −0.16±0.37 in BT group versus 0.04±0.29 in control group, p=0.005 |
RISA [5] | BT: 15; control: 17 | Severe asthma, FEV1 ≥50% | Usual care | Safety: adverse events |
Primary end-point results: 136 respiratory adverse events in BT group (49% mild, 41% moderate, 10% severe) versus 57 respiratory adverse events in control group (49% mild, 47% moderate, 4% severe) |
AIR2 [6] | BT: 196; control: 101 | Severe asthma, FEV1 ≥60% | Sham | Integrated AQLQ score at 6, 9, 12 months |
Primary end-point results: change in integrated AQLQ score: 1.35±1.10 in BT group versus 1.16±1.23 in control group; posterior probability of superiority 96.0% |
Emphysema: endobronchial lung volume reduction | | | | |
Valve: EBV or SVS | | | | |
BeLieVeR-HIFI [9] | EBV: 25; control: 25 | FEV1 <50%, RV>150%, heterogeneous, collateral ventilation assessed by CT scan (visual) | Sham | Percentage change FEV1 at 3 months |
Primary end-point results: FEV1 8.77% (IQR 2.27–35.85) in EBV group versus 2.88% (IQR 0–8.51) in control group (p=0.03) |
STELVIO [10] | EBV: 34; control: 34 | FEV1 <60%, RV>150%, heterogeneous and homogeneous, collateral ventilation assessed by CT scan (visual) and Chartis | Usual care | Improvement from baseline in FEV1, FVC, and 6MWT at 6 months |
Primary end-point results: FEV1: 20.9% (95% CI 11.1–30.7) in EBV group versus 3.1% (95% CI −0.4 to 6.6) in control group, difference between group 17.8% (95% CI 7.6–28.0), p=0.001; FVC: 18.3% (95% CI 9.3–27.3) in EBV group versus 4.0% (95% CI −0.7– 8.6) in control group, difference between group 14.4% (95% CI 4.4–24.3), p=0.005; 6MWT: 19.6% (95% CI 10.4–28.9) in EBV group versus −3.6 (95% CI −6.9–0.4), difference between group 23.3 (95% CI 13.6–32.9), p<0.001 |
IMPACT [11] | EBV: 43; control : 50 | 15%<FEV1<45%; RV >200%, homogeneous, collateral ventilation assessed by Chartis | Usual care | Percentage change FEV1 at 3 months |
Primary end-point results: FEV1: 13.7±28.2% in the EBV group versus −3.2±13.0% in control group; mean difference between groups of 17.0% (95% CI 8.1–25.8%, p=0.0002) |
TRANSFORM [12] | EBV: 65; control: 32 | 15%<FEV1<45%; RV >180%, heterogeneous, collateral ventilation assessed by Chartis | Usual care | Percentage subjects with ≥12% improvement from baseline in FEV1 at 3 months |
Primary end-point results: 55.4% in the EBV group; 6.5% in the control group (p=0.001) |
LIBERATE [13] | EBV: 128; control: 62 | 15%<FEV1<45%; RV >175%, heterogeneous, collateral ventilation assessed by Chartis | Usual care | Percentage subjects with ≥15% improvement from baseline in FEV1 at 12 months |
Primary end-point results: 47.7% in the EBV group; 16.8% in the control group; between-group absolute difference of 31.0 (95% CI 18.0–43.9%; p=0.001) |
REACH [14] | SVS: 66; control: 33 | FEV1 ≤45%, RV ≥150%, heterogeneous, intact interlobar fissure assessed by CT scan (visual) | Usual care | Difference between groups in mean change FEV1 at 3 months |
Primary end-point results: FEV1 0.104±0.18 L in SVS group versus 0.003±0.15 L in control group, p=0.001 |
EMPROVE [15] | SVS: 113; control: 59 | FEV1 <45%, RV >150%, heterogeneous, intact interlobar fissure assessed by CT scan (visual) | Usual care | Difference between groups in mean change FEV1 at 6 months |
Primary end-point results: FEV1 0.099 L (95% CI 0.069–0.128) in SVS group; 0.002 L (95% CI 0.030–0.026); between-group difference 0.101 L (95% CI 0.060–0.141) |
Coils | | | | |
RESET [16] | Coil: 23; control: 24 | FEV1 ≤45%, homogeneous and heterogeneous | Usual care | Difference in quality of life (SGRQ) between both groups at 90 days |
Primary end-point results: SGRQ: –8.11 (−13.83– −2.39) in coil group; 0·25 (−5.58–6.07) in control group; between-group difference: –8.36 (−16.24– −0.47), p=0.04 |
REVOLENS [17] | Coil: 50; control: 50 | FEV1 <50%, RV ≥220%, homogeneous and heterogeneous, formal pulmonary rehabilitation within 12 months | Usual care | Percentage of subjects with 6MWT ≥54 m at 6months |
Primary end-point results: 36% in coil group; 18% in control group; between-group difference: 18% (one-sided 95% CI 4% to ∞; p=0.03) |
RENEW [18] | Coil: 157; control: 158 | FEV1 <45%, RV ≥225% (lowered to ≥175% after enrolment of 169 patients), homogeneous and heterogeneous | Usual care | Difference in the 6MWT changes between groups at 12 months |
Primary end-point results: 10.3 m in coil group; −7.6 m in control group; between-group difference: 14.6 m (97.5% CI 0.4 m to ∞; one-sided p=0.02) |
TVA | | | | |
STEP-UP [19] | TVA: 46; control: 24 | FEV1 20–45%, heterogeneous upper lobe predominant emphysema | Usual care | Changes in FEV1 and quality of life (SGRQ) between groups at 6 months |
Primary end-point results: FEV1: 11.0±16.2% in TVA group; −3.7±11.1% in control group; difference between group: 14.7% (95% CI 7.8–21.5), p<0.0001 SGRQ: −9.7±14.4 in TVA group; −0.0±9.8 in control group; difference between groups −9.7 (95% CI −15.7– −3.7), p=0.0021 |
COPD: TLD | | | | |
AIRFLOW-2 [20] | TLD: 41; control: 41 | FEV1 30–60%, symptomatic COPD (mMRC ≥2 or CAT ≥10) | Sham | Safety: difference between groups in respiratory adverse events at 3–6.5 months |
Primary end-point results: 32% in TLD group versus 71% in control group, p=0.008; OR 0.19 (95% CI 0.0750–0.4923), p=0.0006 |