Withdrawal of Inhaled Corticosteroids in Patients with COPD – A Prospective Observational Study

Figures & data

Figure 1 Study design.

Abbreviations: ICS, inhaled corticosteroids; FEV1, forced expiratory volume in 1st second.

Table 1 Baseline Characteristics

Total Population	Completing the Study (n = 85)
Gender (%M)	36 (42.3)
BMI, mean (range)	25 (12–44)
Age – years, mean (range)	70.1 (51–94)
GOLD (%)
A	5 (5%)
B	20 (21%)
C	9 (9%)
D	62 (65%)
MRC (%)
1	1 (1.2%)
2	19 (22.4%)
3	33 (38.8%)
4	25 (29.4%)
5	11 (7.7%)
Smoking history
Former smokers no. (%)	74 (77.1)
Current smokers no. (%)	22 (22.9)
Pack years, mean (±)	45.55 (8–90)
Daily dose of ICS, mean (µg)	740
Lung function
FEV1	0.97 (0.25–2.30)
FEV1% pred.	40.55 (12–93)
No. of patients with exacerbations prior to inclusion (%)	45 (52.9)
Blood eosinophil conc.	0.22 (0–1.22)
Exa. prior to inclusion	0.24 (0–1.22)
No exa. prior to inclusion	0.19 (0–0.56)
Charlson comorbidity Index
0 (%)	15 (15.6)
1 (%)	28 (29.2)
≥2 (%)	53 (55.2)

Abbreviations: %M, percent males; BMI, body mass index; no., numbers; ICS, inhaled corticosteroids; FEV₁, forced expiratory volume in 1st second; pred., predicted; conc., concentration; exa, exacerbations.

Table 2 Exacerbations, Use of Antibiotics and FEV1 During Follow-Up

Time from Study Entry	1 Month		3 Months		6 Months
	+ ICS (No. 28)	- ICS (No. 34)	+ ICS (No. 44)	- ICS (No. 34)	+ ICS (No. 51)	- ICS (No. 34)
No of pts with exacerbations	23	6	19	7	22	9
No of pts treated with antibiotics	20	6	11	3	16	8
FEV1 L (%), mean	0.96 (41)	1.00 (41)	0.97 (41)	0.97 (40)	0.91 (39)	0.96 (39)

Abbreviations: FEV1, forced expiratory volume in 1st second; + ICS, resumed inhaled corticosteroids; - ICS, withdrawal from inhaled corticosteroids; no, numbers; pts, patients.

Table 3 Baseline Characteristics Among the 2 Groups

Total Population	Concluding the Study (n = 85)
Groups	No ICS (n = 34)	Resumed ICS (n = 51)	p-value
Gender (%M)	16 (47.1)	20 (40.0)	0.53
BMI, mean (range)	25.7 (17–38)	24.7 (12–44)
Age – years, mean (±)	69.9 (51–86 yrs)	70.5 (52–94 yrs)	0.64
GOLD (%)
A	2 (5.9)	2 (3.9)
B	10 (29.4)	9 (17.6)
C	2 (5.9)	6 (11.8)
D	20 (58.8)	34 (66.7)
MRC (%)
1	1 (2.9%)	1 (2%)
2	10 (29.4%)	8 (15.7%)
3	12 (35.3%)	19 (37.3%)
4	7 (20.6%)	16 (31.4%)
5	4 (11.8%)	7 (13.7%)
Smoking history
Former smokers (%)	24 (70.6)	42 (82.4)	0.14
Current smokers (%)	10 (29.4)	9 (17.6)	0.22
Pack years, mean	45.24	44.74
Daily dose of ICS, mean (µg)	708.8	748.0	0.44
Lung function
FEV1 liters	1.00	0.96	0.63
FEV1% predicted	41.0	40.5
Blood eosinophil conc.	0.17	0.25	0.07
No. of patients with exacerbations prior to inclusion (%)	18 (53)	27 (54)	0.93
Charlson comorbidity Index
0 (%)	5 (14.7)	9 (17.6)	0.72
1 (%)	9 (26.5)	16 (31.4)	0.63
≥2 (%)	20 (58.8)	26 (51.0)	0.48

Abbreviations: ICS, inhaled corticosteroids; %M, percent males; BMI, body mass index; n, numbers; FEV₁, forced expiratory volume in 1st second; conc., concentration; no., numbers.

Figure 2 Exacerbations according to treatment. Numbers in parentheses indicate percentages.

Abbreviation: ICS, inhaled corticosteroids.

Table 4 Exacerbations and Lung Function During Follow-Up According to Treatment

	Patients without ICS During Follow-Up (n = 34)	Patients Resuming ICS During Follow-Up (n = 51)	p-value
No. of patients with exacerbations (%)	15 (44.1%)	34 (68%)	0.09
ΔFEV1	0.04 L	−0.07 L	0.55

Abbreviations: ICS, inhaled corticosteroids; n, numbers; no., numbers; FEV1, forced expiratory volume in 1st second.

Table 5 EOS According to Phenotype and Use of ICS

Resumed ICS (n = 51)
	Exacerbations (n = 34)	No Exacerbations (n = 17)	p-value
EOS at baseline	0.24	0.28	0.61
EOS at 3 months	0.25	0.21	0.49
ICS Withdrawal (n = 34)
	Exacerbations (n = 15)	No Exacerbations (n = 19)
EOS at baseline	0.15	0.18	0.44
EOS at 3 months	0.17	0.24	0.23
EOS in Exacerbators (n = 49)
	Resumed ICS (n = 34)	ICS Withdrawal (n = 15)
EOS at baseline	0.24	0.15	0.15
EOS at 3 months	0.25	0.17	0.14
EOS No Exacerbations (n = 36)
	Resumed ICS (n = 17)	ICS Withdrawal (n = 19)
EOS at baseline	0.28	0.18	0.21
EOS at 3 months	0.21	0.24	0.66

Abbreviations: EOS, blood eosinophil count; ICS, inhaled corticosteroids; n, numbers.