Prevention of COPD exacerbation by lysozyme: a double-blind, randomized, placebo-controlled study

Figures & data

Table 1 Baseline patient characteristics

Characteristics	LYS 270 mg	Placebo
	(n=202)	(n=204)
Sex, n
Male	183	186
Female	19	18
Age (years), mean ± SD	68.8±9.3	70.3±7.2
Duration of COPD
Years, mean ± SD	4.6±4.2	5.0±4.6
<2 years, n	40	35
≥2 years, n	162	169
Subtype of COPD, n
Airway dominant	49	43
Emphysema	153	161
Smoking status, n
Current	62	61
Ex	140	143
Gold stage, n
II	119	133
III	73	60
IV	10	11
Complicated bronchial asthma, n (%)	90 (44.6)	95 (53.4)
Exacerbations in past 52 weeks, mean ± SD	1.8±1.0	1.6±1.0
One, n (%)	107 (53.2)	122 (59.8)
Two or more, n (%)	94 (46.8)	82 (40.2)
Hospitalization or emergency admission in past 52 weeks, n (%)	29 (14.4)	21 (10.3)
Pulmonary function, mean±SD
FEV1 (L)	1.42±0.5	1.41±0.5
Predicted FEV1 (%)	54.39±15.8	54.76±15.0
FVC (L)	2.85±0.8	2.81±0.7
COPD assessment test (total score), mean ± SD	12.9±6.6	13.4±7.3
GOLD classification, n (%)
A	18 (9.0)	23 (11.3)
B	46 (22.9)	52 (25.5)
C	43 (21.4)	44 (21.6)
D	94 (46.8)	85 (41.7)
Standard treatment (multiple count), n (%)
LABA	89 (44.1)	83 (40.7)
LAMA	136 (67.3)	151 (74.0)
ICS/LABA	118 (58.4)	123 (60.3)
ICS	17 (8.4)	15 (7.4)
Xanthine	58 (28.7)	58 (28.4)

Abbreviations: GOLD, Global Initiative for Chronic Obstructive Lung Disease; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; LABA, long-acting beta-agonist; LAMA, long-acting muscarinic antagonist; LYS, lysozyme; SD, standard deviation.

Table 2 Exacerbation frequency

Group	LYS	Placebo	P-value
All patients (n=405)	1.4	1.2	0.292
Duration of COPD <2 years (n=75)	0.7	1.0	0.142
Airway dominant (n=91)	1.2	1.6	0.128
Current smoker (n=122)	1.0	1.2	0.198

Note: A Poisson regression analysis was performed, P<0.05.

Abbreviation: LYS, lysozyme.

Figure 1 Kaplan–Meier plots showing the time to first exacerbation in (A) all patients, (B) patients with airway-dominant phenotype, and (C) patients with <2 years of disease duration.

Abbreviations: CI, confidence interval; LYS, lysozyme.

Figure 2 Changes in FEV₁ from the baseline (mean ± standard error).

Abbreviations: FEV₁, forced expiratory volume in 1 second; LYS, lysozyme.

Figure 3 Mean changes in CAT scores from baseline.

Note: (A) Summary score, (B) item 2 (mucus volume), and (C) item 4 (breathlessness).
Abbreviations: CAT, COPD assessment test; LYS, lysozyme.