Comparison of ICS dose reduction vs. montelukast discontinuation for step-down therapy in well-controlled asthma: a pilot randomized controlled trial

Table 2 Asthma control outcomes in different treatment phases– ICS taper with montelukast continuation vs. montelukast discontinuation without ICS taper

Parameter	Baseline			After one month			After three months
Parameter	A^* N = 37	B^** N = 34	P value	A^* N = 35	B^** N = 29	P value	A^* N = 35	B^** N = 24	P value
ACT score	22.7 ± 1.92	22.45 ± 2.64	0.14	23.3 ± 1.7	23.5 ± 1.8	0.43	24.0 ± 1.45	22.4 ± 3.2	0.42
Δ^*** ACT score	-	-	-	0.7 ± 1.73	1.3 ± 2.4	0.02	1.4 ± 2.3	0.4 ± 3.2	0.85
D-NCS	1.23 ± 1.33	1.34 ± 1.28	0.50	0.7 ± 0.5	0.8 ± 0.8	0.40	0.6 ± 0.9	0.5 ± 0.5	0.61
Δ D-NCS	-	-	-	-0.5 ± 1.2	-0.5 ± 1.1	0.78	-0.7 ± 1.7	-0.8 ± 1.2	0.62
N-NCS	1.35 ± 0.73	1.50 ± 1.14	0.16	0.3 ± 0.2	0.4 ± 0.7	0.26	0.3 ± 0.3	0.2 ± 0.4	0.17
Δ N-NCS	-	-	-	-0.4 ± 1.5	-0.7 ± 1.4	0.83	-0.6 ± 1.8	-1.1 ± 1.6	0.85
FEV1/FVC (%)	81.19 ± 14.84	75.47 ± 10.19	0.10	87.5 ± 11.7	85.2 ± 9.8	0.27	84.9 ± 10.1	88.6 ± 7.61	0.56
Δ FEV1/FVC	-	-	-	7.7 ± 13.3	9.5 ± 10.4	0.33	14.9 ± 12.7	12.1 ± 11.3	0.39
FEV1	70.62 ± 16.69	73.28 ± 15.08	0.53	85.6 ± 10.4	84.5 ± 10.8	0.85	91.5 ± 8.8	86.9 ± 6.1	0.14
Δ FEV1	-		-	14.8 ± 11.6	13.8 ± 10.9	0.85	20.2 ± 12.5	17.6 ± 12.3	0.93
FVC	79.36 ± 13.26	84.76 ± 17.48	0.17	89.6 ± 10.9	89.3 ± 10.1	0.68	95.0 ± 10.0	91.5 ± 6.14	0.35
ΔFVC	-	-	-	9.5 ± 8.6	9.1 ± 11.9	0.08	14.9 ± 12.8	12.2 ± 11.3	0.64
Adherence (%)	100	100	-	97.1	100	0.88	94.2	91.6	0.89
Treatment failure (number of patients)	-	-	-	0	2	0.14	0	5	0.01

*A: ICS taper with montelukast continuation, **B: Montelukast discontinuation without ICS taper, ***Difference from baseline
Abbreviations: ACT score = Asthma Control Test score, D-CSS: Daytime Cough Symptom Score, FVC = Forced vital capacity, N-CSS: Nighttime Cough Symptom Score, SD = standard deviation, FEV1: forced expiratory volume in 1 s

ISSN: 1471-2466