Effect of indacaterol on lung deflation improves cardiac performance in hyperinflated COPD patients: an interventional, randomized, double-blind clinical trial

Figures & data

Figure 1 Consolidated Standards of Reporting Trials (CONSORT) 2010 flow diagram.

Notes: The diagram graphically outlines the design and conduct of the clinical study.
Abbreviations: DLCO, diffusing lung capacity for carbon monoxide; SpO₂, peripheral oxygen saturation; TTE, trans-thoracic echocardiography; VAS, visual analog scale.

Table 1 Demographic, anthropometric, and baseline lung function variables

Variable	Actual value	Percent of predicted values
Study participants, n	40
Age, years	71.6±7.10
Sex, M/F	27/13
Height, m	1.64±0.10
Weight, kg	65.80±15.9
BMI	24.60±5.10
Smoking history, pack-years	41.20±10.60
GOLD stage I–II, n	0–10
GOLD stage III–IV, n	13–17
FEV1, L	0.96±0.43	41.40±17.20
VC, L	2.71±0.85	86.70±15.70
RVo, L	4.70±1.34	201.40±59.20
Room air SpO2	92.60±2.30
HR, bpm	71.60±10.50
VAS dyspnea score	1.40±1.90

Note: Data are shown as mean ± standard deviation.

Abbreviations: BMI, body mass index; FEV₁, forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; HR, heart rate; RVo, residual volume; SpO₂, peripheral capillary oxygen saturation; VAS, visual analog scale; VC, vital capacity; bpm, beats per minute.

Table 2 Dynamic respiratory parameters after 60 and 180 minutes’ treatment with indacaterol or placebo

Parameter	Indacaterol			Placebo
	T0	ΔT60	ΔT180	T0	ΔT60	ΔT180
IC, L	1.94±0.64	+0.14±0.35#,*	+0.12±0.31#,*	1.91±0.63	+0.03±0.24	+0.02±0.22
IC, % pred	84.94±21.50	+9.51±22.91#,*	+7.85±17.54#,*	83.7±21.70	+1.02±6.30	+0.90±5.90
VC, L	2.71±0.85	+0.16±0.25#,*	+0.22±0.27#,*	2.70±0.87	+0.01±0.14	−0.04±0.21
VC, % pred	86.68±15.69	+6.85±9.75#,*	+9.00±10.58#,*	87.05±15.23	+0.80±3.80	−0.50±4.20
FEV1, L	0.96±0.43	+0.07±0.12#,*	+0.08±0.13#,*	0.94±0.46	−0.01±0.16	+0.01±0.15
FEV1, % pred	41.45±17.16	+7.75±10.9#,*	+7.66±11.53#,*	40.65±17.16	+0.80±3.10	+0.20±4.50
VAS dyspnea	1.40±1.90	−0.48±1.01#,*	−0.80±1.30#,*	1.30±1.92	−0.20±0.55	−0.25±1.15

Notes: Data are shown as mean ± standard deviation.

# P≤0.05 vs T0 (baseline);

* P≤0.05 vs placebo. Δ = post-(T60 and T180) (60 and 180 minutes) minus pretreatment (T0) values.

Abbreviations: FEV₁, forced expiratory volume in 1 second; IC, inspiratory capacity; VC, vital capacity; VAS, visual analog scale; % pred, percent predicted.

Table 3 Static respiratory parameters after 60 and 180 minutes’ treatment with indacaterol or placebo

Parameter	Indacaterol			Placebo
	T0	ΔT60	ΔT180	T0	ΔT60	ΔT180
TLC, L	7.36±1.41	−0.32±0.75*	−0.27±0.92*	7.33±1.39	−0.04±0.82	+0.03±0.85
TLC, % pred	130.61±22.65	−1.10±4.37*	−2.58±11.52*	129.50±21.87	+0.20±5.20	+0.90±9.87
RVo, L	4.70±1.34	−0.48±0.85#,*	−0.56±1.03#,*	4.74±1.31	−0.02±0.90	+0.04±0.98
RVo, % pred	201.42±59.25	−8.61±13.44#,*	−9.14±16.62#,*	205.28±60.08	−1.20±14.52	+1.14±15.9
ITGV, L	5.50±1.42	−0.43±6.55#,*	−0.54±0.91#,*	5.53±1.41	−0.06±7.82	+0.01±0.95
ITGV, % pred	174.92±45.01	−6.55±10.97#,*	−7.81±12.36#,*	176.47±44.87	+1.2±11.12	−0.01±11.49
sRAW, kPa/s	4.31±2.39	−0.75±0.87#,*	−0.68±0.85#,*	4.26±2.28	−0.07±0.90	+0.02±0.80
sRAW, % pred	393.22±219.26	−14.40±21.29#,*	−13.11±18.02#,*	390.14±221.20	−0.80±16.42	+0.60±18.26

Notes: Data are shown as mean ± standard deviation.

# P≤0.05 vs T0 (baseline);

* P≤0.05 vs placebo. Δ = post-(T60 and T180) (60 and 180 minutes) minus pretreatment (T0) values.

Abbreviations: ITGV, intrathoracic gas volume; kPa/s, kilopascal per second; RVo, residual volume; sRAW, specific airway resistance; TLC, total lung capacity; % pred, percent predicted.

Table 4 Cardiac performance after 60 and 180 minutes’ treatment with indacaterol or placebo

Parameter	Indacaterol			Placebo
	T0	ΔT60	ΔT180	T0	ΔT60	ΔT180
TAPSE, mm	22.30±3.52	+0.05±1.28*	+0.41±1.07#,*	21.90±3.83	−0.03±1.26	+0.02±3.80
PAPs, mmHg	33.03±8.10	+0.71±5.50	−0.08±7.76	32.78±8.30	+0.77±4.46	+0.24±5.76
DT-TR, msec	207.80±64.90	+9.93±36.31*	+11.90±32.86#,*	206.70±65.84	+2.60±35.90	+3.80±38.90
LVEF, %	61.80±5.25	−0.03±1.90	−0.25±2.20	60.60±6.21	+0.09±2.12	−0.14±2.35
DT-MR, msec	230.18±58.69	+3.98±38.24	+4.33±38.79	228.25±59.33	+1.12±37.52	+1.38±36.81
HR, bpm	71.54±10.60	−1.95±5.30#,*	−2.00±6.10#,*	70.21±9.40	−0.80±1.20	+0.60±1.30

Notes: Data are shown as mean ± standard deviation.

# P≤0.05 vs T0 (baseline);

* P≤0.05 vs placebo. Δ = post-(T60 and T180) (60 and 180 minutes) minus pretreatment (T0) values.

Abbreviations: bpm, beats per minute; DT-TR, tricuspid E-wave deceleration time; HR, heart rate; LVEF, left ventricular ejection fraction; DT-MR, mitral E-wave deceleration time; msec, milliseconds; PAPs, systolic pulmonary artery pressure; TAPSE, tricuspid annular plane systolic excursion.