Assessment of bronchodilator responsiveness to salbutamol or ipratropium using different criteria in treatment-naïve patients with asthma and COPD

Figures & data

Figure 1. A flowchart of the study design.

Table 1. Results of bronchodilation reversibility testing with SABA or SAMA (N = 105).

	SABA	SAMA	p-values*
pre-BD FEV1, L	1.83 ± 0.63	1.81 ± 0.60	0.40
pre-BD FEV1, %pred	65 ± 19	64 ± 14	0.38
pre-BD FVC, L	3.18 ± 0.94	3.14 ± 0.88	0.23
pre-BD FVC, %pred	87 ± 19	86 ± 17	0.21
pre-BD FEV1/FVC	0.57 ± 0.09	0.58 ± 0.09	0.50
Change in FEV1 after 15 minutes	160 ± 152 mL	204 ± 142 mL	0.02
	10.0 ± 9.6%pre-BD	11.7 ± 9.0%pre-BD	0.17
	5.6 ± 5.0%pred	7.1 ± 4.8%pred	0.04
Change in FEV1 after 30 minutes	203 ± 214 mL^##	286 ± 170 mL^##	<0.001
	12.2 ± 12.6%^#	16.4 ± 9.7%^##	0.004
	7.0 ± 6.8%pred^##	10.0 ± 5.4%pred^###	<0.001
Change in FVC after 15 minutes	140 ± 278 mL	300 ± 305 mL	<0.0001
	4.9 ± 10.5%pre-BD	9.7 ± 10.3%pre-BD	<0.0001
	3.6 ± 7.1%pred	7.9 ± 7.9%pred	<0.0001
Change in FVC after 30 minutes	205 ± 309 mL^##	439 ± 370 mL^###	<0.0001
	6.9 ± 10.9%pre-BD^##	14.2 ± 11.8%pre-BD^###	<0.0001
	5.4 ± 8.0%pred^###	11.7 ± 9.1%pred^###	<0.0001

Data are shown as mean ± SD and were compared with paired t-tests. *SABA vs. SAMA. ^#p < 0.01, ^##p < 0.001, ^###p < 0.0001 vs. corresponding values at 15 minutes. Pred: predicted.

Table 2. Agreement of bronchodilator responsiveness (BDR) to salbutamol after 15 and 30 minutes according to the 2005 and 2021 ERS/ATS criteria.

	Number of patients with a significant BDR according to the 2021 criteria
		BDR +	BDR -	Total
	BDR after 15 minutes
Number of patients with a significant BDR according to the 2005 criteria	BDR +	30	6	36
	BDR -	2	67	69
	Total	32	73
	Agreement: 92.4%
	BDR after 30 minutes
	BDR +	46	6	52
	BDR -	1	52	53
	Total	47	58
	Agreement: 93.3%

Table 3. Agreement of bronchodilator responsiveness to ipratropium after 15 and 30 minutes according to the 2005 and 2021 ERS/ATS criteria.

	Number of patients with a significant BDR according to the 2021 criteria
		BDR +	BDR -	Total
	BDR after 15 minutes
Number of patients with a significant BDR according to the 2005 criteria	BDR+	41	10	51
	BDR-	2	52	54
	Total	43	62
	Agreement: 88.6%
	BDR after 30 minutes
	BDR+	67	6	73
	BDR-	0	32	32
	Total	67	38
	Agreement: 94.8%

Table 4. Binominal logistic regression analysis of factors associated with a significant bronchodilator response to salbutamol after 30 minutes (N = 105).

	BDR according to the 2005 ERS/ATS criteria			BDR according to the 2021 ERS/ATS criteria
Variable	OR	95% CI	p-value	OR	95% CI	p-value
Age	1.00	0.96–1.05	0.88	1.01	0.97–1.05	0.64
Sex Female Male	reference
	2.10	0.97–4.64	0.06	1.73	0.79–3.81	0.17
Body mass index, kg/m [2]	0.93	0.85–1.01	0.08	0.95	0.87–1.04	0.27
Smoking status Non-smoker Current smoker Former smoker	reference
	1.10	0.4–3.02	0.86	0.91	0.33–2.51	0.86
	0.67	0.19–2.33	0.53	0.43	0.11–1.54	0.20
Pack-years	1.00	0.99–1.02	0.88	1.00	0.98–1.02	0.93
Co-morbidities 0–1 co-morbidity ≥ 2 co-morbidities
	reference
	1.53	0.71–3.33	0.28	1.06	0.49–2.3	0.88
Pre-BD FEV1, L	0.65	0.34–1.21	0.18	0.57	0.29–1.07	0.09
Pre-BD FEV1, %pred	0.97	0.95–0.99	0.01	0.97	0.95–0.99	0.01
Pre-BD FVC, L	0.98	0.65–1.47	0.91	0.96	0.69–1.44	0.83
Pre-BD FVC, %pred	0.98	0.96–1	0.14	0.99	0.97–1.01	0.22
Total CAT score	1.02	0.97–1.08	0.48	1.03	0.97–1.09	0.34
Cough no yes
	reference
	6.55	1.64–43.86	0.02	12.0	2.23–223.08	0.02
Sputum production no yes
	reference
	0.97	0.43–2.18	0.94	1.44	0.64–3.32	0.38
Dyspnea on exertion no yes
	reference
	0.84	0.27–2.52	0.75	0.91	0.3–2.81	0.87
Dyspnea at rest no yes
	reference
	0.69	0.25–0.88	0.48	0.67	0.23–1.83	0.44

BDR: bronchodilator responsiveness, CAT: COPD Assessment Test, CI: confidence interval, OR: odds ratio, pre-BD: pre-bronchodilator, pred: predicted.

Table 5. Binominal logistic regression analysis of factors associated with a significant bronchodilator response to ipratropium after 30 minutes (N = 105).

	BDR according to the 2005 ERS/ATS criteria			BDR according to the 2021 ERS/ATS criteria
Variable	OR	95% CI	p-value	OR	95% CI	p-value
Age	0.97	0.92–1.01	0.19	0.97	0.93–1.02	0.25
Sex Female Male	reference
	1.54	0.67–3.57	0.31	1.31	0.59–2.93	0.51
Body mass index, kg/m [2]	1.01	0.93–1.11	0.77	0.98	0.90–1.07	0.63
Smoking status Non-smoker Current smoker Former smoker	reference
	1.41	0.46–4.03	0.53	0.98	0.33–2.76	0.97
	1.00	0.27–3.72	1.00	0.81	0.22–2.92	0.74
Pack-years	1.00	0.98–1.02	0.99	1.00	0.98–1.02	0.89
Co-morbidities 0–1 co-morbidity ≥ 2 co-morbidities
	reference
	0.55	0.23–1.28	0.17	0.42	0.18–0.95	0.04
Pre-BD FEV1, L	1.14	0.57–2.35	0.72	1.14	0.59–2.28	0.70
Pre-BD FEV1, %pred	0.99	0.97–1.01	0.52	1.00	0.97–1.02	0.89
Pre-BD FVC, L	1.32	0.82–2.19	0.26	1.44	0.91–2.36	0.13
Pre-BD FVC, %pred	1.00	0.98–1.03	0.86	1.02	0.99–1.04	0.21
Total CAT score	1.02	0.96–1.08	0.62	1.01	0.95–1.07	0.86
Cough no yes
	reference
	2.18	0.65–7.16	0.12	1.61	0.48–5.24	0.43
Sputum production no yes
	reference
	1.23	0.51–2.9	0.65	1.43	0.62–3.28	0.40
Dyspnea on exertion no yes
	reference
	0.81	0.21–2.59	0.73	0.60	0.16–1.91	0.41
Dyspnea at rest no yes
	reference
	1.81	0.59–6.8	0.33	1.73	0.60–5.80	0.33

BDR: bronchodilator responsiveness, CAT: COPD Assessment Test, CI: confidence interval, OR: odds ratio, pre-BD: pre-bronchodilator, pred: predicted.

Table 6. Clinical characteristics of groups based on BDR after 30 minutes.

		BDR according to the 2005 ERS/ATS criteria					BDR according to the 2021 ERS/ATS criteria
	Total	SABA+	SAMA+	SABA+ SAMA+	SABA-SAMA-	p-value*	SABA+	SAMA+	SABA+ SAMA+	SABA-SAMA-	p-value*
Number	105	13	34	39	19	NA	12	32	35	26	NA
Age	65 ± 10	65 ± 6	63 ± 10	65 ± 10	68 ± 10	0.38	66 ± 5	63 ± 9	65 ± 10	67 ± 11	0.44
Male/female	57/48	8/5	17/17	25/14	7/12	0.22	8/4	17/15	21/14	11/15	0.44
BMI, kg/m [2]	27.0 ± 4.7	25.2 ± 5.2	27.8 ± 5.3	26.4 ± 4.3	27.8 ± 4.2	0.29	26.6 ± 5.1	27.3 ± 5.1	26.3 ± 4.6	27.5 ± 4.4	0.73
Smoking habit, N Never smoker Ex-smoker Current smoker	20 20 65	3 2 8	6 7 21	7 6 26	4 5 10	0.95	2 1 9	5 7 20	8 5 22	5 7 14	0.78
Pack-years	31 ± 24	23 ± 26	31 ± 23	31 ± 23	31 ± 26	1.00	40 ± 28	34 ± 22	28 ± 23	28 ± 24	0.38
Number of co-morbidities, N 0–1 ≥2	50 55	2 11	18 16	20 19	10 9	0.10	2 10	17 15	20 15	11 15	0.09
Total CAT score	15 ± 7	14 ± 7	14 ± 6	16 ± 7	15 ± 7	0.68	14 ± 7	14 ± 6	16 ± 7	15 ± 8	0.43
Pre-BD FEV1, L	1.82 ± 0.60	1.77 ± 0.55	1.93 ± 0.68	1.76 ± 0.57	1.75 ± 0.57	0.64	1.73 ± 0.55	1.97 ± 0.64	1.74 ± 0.59	1.77 ± 0.60	0.39
Pre-BD FEV1, %pred	64 ± 17	61 ± 14	68 ± 20	61 ± 17	68 ± 13	0.24	58 ± 14	69 ± 19	61 ± 18	67 ± 14	0.15
Pre-BD FVC, L	3.16 ± 0.89	3.22 ± 0.87	3.31 ± 0.89	3.19 ± 0.91	2.82 ± 0.88	0.28	3.24 ± 0.93	3.40 ± 0.83	3.18 ± 0.91	2.82 ± 0.87	0.09
Pre-BD FVC, %pred	87 ± 17	86 ± 18	90 ± 18	85 ± 18	85 ± 15	0.50	85 ± 19	92 ± 17	86 ± 17	82 ± 16	0.14
Pre-BD FEV1/FVC	0.57 ± 0.09	0.55 ± 0.09#	0.58 ± 0.11	0.56 ± 0.08 #	0.62 ± 0.05	0.03	0.54 ± 0.07 ##	0.58 ± 0.10	0.55 ± 0.09 ##	0.62 ± 0.06	0.004
FEV1 change after SABA, mL	204 ± 214	311 ± 126	74 ± 150	354 ± 205	54 ± 108	<0.001	340 ± 119	81 ± 163	362 ± 210	79 ± 109	<0.001
FEV1 change after SABA, %	12.2 ± 12.6	19.1 ± 8.6	4.4 ± 9.2	21.0 ± 11.4	3.5 ± 6	<0.001	21.7 ± 8.8	4.2 ± 9.0	21.8 ± 11.4	4.8 ± 6.0	<0.001
FEV1 change after SAMA, mL	286 ± 170	127 ± 55	354 ± 130	361 ± 162	122 ± 100	<0.001	131 ± 70	357 ± 133	381 ± 155	134 ± 105	<0.001
FEV1 change after SAMA, %	16.4 ± 9.7	7.3 ± 4.0	20.2 ± 7.9	20.9 ± 8.7	6.5 ± 5.2	<0.001	7.5 ± 4.4	19.9 ± 8.1	22.6 ± 7.9	7.8 ± 5.8	<0.001
Clinical diagnosis, N Bronchial asthma COPD	53 52	9 4	10 24	28 11	6 13	<0.001	9 3	9 23	27 8	8 18	<0.001

Baseline spirometric data are calculated from the individual mean values of pre-SABA and pre-SAMA measurements. Data are shown as mean ± SD. Subgroups were compared with ANOVA and Tukey post-hoc tests or chi-square tests*. #p<0.05, ##p<0.01 vs. SABA-SAMA-. BD: bronchodilator, BMI: body mass index, CAT: COPD Assessment Test, NA: not applicable, pred: predicted. NA: not applicable.

Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease 2019 report. 2019. Available from: https://www.copdgold.org

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Data availability statement

The data that support the findings of this study are available from the corresponding author, [Z.L.], upon reasonable request.