. 2021 Jan 13;30(159):200029. doi: 10.1183/16000617.0029-2020

TABLE 1.

Characteristics of randomised controlled trials

Study [Ref.]	Subjects N	Main inclusion criteria	Control group	Primary end-point
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
AIR [4]	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
RISA [5]	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
AIR2 [6]	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
BeLieVeR-HIFI [9]	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
STELVIO [10]	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
IMPACT [11]	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
TRANSFORM [12]	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
LIBERATE [13]	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
REACH [14]	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
EMPROVE [15]	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
RESET [16]	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
REVOLENS [17]	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
RENEW [18]	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
STEP-UP [19]	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
AIRFLOW-2 [20]	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

BT: bronchial thermoplasty; EBV: endobronchial valve; SVS: Spiration valve system; TVA: thermal vapor ablation; TLD: targeted lung denervation; LABA: long-acting β-agonist; FEV₁: forced expiratory volume in 1 s; AQLQ: Asthma Quality of Life Questionnaire; RV: residual volume; CT: computed tomography; FVC: forced vital capacity; 6MWT: 6-min walk test; SGRQ: St George's Respiratory Questionnaire; mMRC: modified Medical Research Council dyspnoea score; CAT: COPD Assessment Test.