Chronic obstructive pulmonary disease treated with inhaled medium- or high-dose corticosteroids: a prospective and randomized study focusing on clinical efficacy and the risk of pneumonia

Figures & data

Figure 1 Subject numbers.

Abbreviations: HD, high dose; MD, medium dose.

Table 1 Baseline demographic characteristics of study subjects with chronic obstructive pulmonary disease (COPD)

Variables	COPD-HD (n=106)	COPD-MD (n=111)	P-value
Age	66.4±20.3	68±23.4	0.49
Sex (M/F)	92/14	93/18	0.64
Smoking (pack-years)	27.4±16.5	29.1±19.3	0.52
Severity class
GOLD I (%)	0 (0)	0 (0)	0.41
GOLD II (%)	29 (27.4)	24 (21.6)
GOLD III (%)	47 (44.3)	51 (45.9)
GOLD IV (%)	30 (28.3)	36 (32.5)
FEV1, L (% of predicted)	1.24 (46.1)	1.27 (47.2)	0.32
FVC, L (% of predicted)	2.31 (56.3)	2.26 (54.7)	0.41
FEV1/FVC (% of predicted)	46.5±18.9	49.7±20.3	0.14
FEV1 reversibility (%)	5.6±3.6	4.9±4.1	0.44
CAT baseline	18±6	19±7	0.23
Comorbidity
Hypertension (%)	51 (48.1)	57 (51.4)	0.37
Diabetes mellitus (%)	36 (33.9)	38 (34.2)	0.51
CAD (%)	11 (11.3)	14 (12.6)	0.18
CHF (%)	18 (16.9)	25 (22.5)	0.13
Medications at baseline before R
Theophylline (%)	67 (63.2)	69 (62.1)	0.55
Indacaterol (%)	34 (32.1)	37 (33.3)	0.59
Tiotropium (%)	59 (55.7)	64 (57.7)	0.48
ICS (%)	41 (38.7)	47 (42.3)	0.34

Notes: All values are shown as means ± standard deviation.

Abbreviations: HD, high dose; MD, medium dose; GOLD, Global initiative for chronic Obstructive Lung Disease; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; CAT, COPD-assessment test; CAD, coronary artery disease; CHF, chronic heart failure; R, randomization; ICS, inhaled corticosteroid.

Figure 2 Change in forced expiratory volume in 1 second (FEV₁) in chronic obstructive pulmonary disease patients with high-dose (HD) or medium-dose (MD) treatment.

Note: *P<0.05.

Figure 3 Change in forced vital capacity (FVC) in chronic obstructive pulmonary disease patients with high-dose (HD) or medium-dose (MD) treatment.

Note: *P<0.05.

Table 2 Treatment response in chronic obstructive pulmonary disease (COPD) patients with high and medium doses of fluticasone/salmeterol

Variables	COPD-HD (n=106)	COPD-MD (n=111)	P-value
Lung function after treatment
FEV1, L (% of predicted)	1.35 (56.2)	1.31 (51.7)	0.02*
FVC, L (% of predicted)	2.53 (54.8)	2.37 (52.5)	0.04*
FEV1 change from baseline, mL	103.9±26.6	51.4±19.7	<0.01*
FEV1 change in GOLD II	114.2±32.5	73.1±25.6	<0.01*
FEV1 change in GOLD III	81.6±28.7	36.4±31.3	<0.01*
FEV1 change in GOLD IV	53.2±16.3	18.7±8.4	<0.01*
FVC change from baseline (mL)	218.4±46.2	107.8±38.9	<0.01*
FVC change in GOLD II	237.1±41.6	125.6±40.2	<0.01*
FVC change in GOLD III	168.7±39.3	87.9±38.6	<0.01*
FVC change in GOLD IV	125.9±35.7	60.2±31.4	<0.01*
CAT in 26 weeks	15±7	16±9	0.26
CAT in 52 weeks	13±5	16±7	0.05*
Hoarseness	6 (5.7)	10 (9.0)	0.41
Exacerbation rate (per patient per year)	0.16	0.34	<0.01*
Pneumonia rate (per patient per year)	0.08	0.10	0.38
Admission rate (per patient per year)	0.02	0,01	0.51
Streptococcal pneumonia, %	5 (29.4)	8 (21.1)	0.16
Hemophilus parainfluenzae, %	2 (11.8)	9 (23.7)	0.02*
Klebsiella pneumonia, %	3 (17.6)	5 (13.2)	0.24

Notes:

* P<0.05; all values are shown as means ± standard deviation.

Abbreviations: HD, high dose; MD, medium dose; GOLD, Global initiative for chronic Obstructive Lung Disease; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; CAT, COPD-assessment test.