Budesonide/Formoterol Anti-Inflammatory Reliever and Maintenance or Fluticasone Propionate/Salmeterol Plus As-Needed, Short-Acting β₂ Agonist: Real-World Effectiveness in pAtients without Optimally Controlled asThma (REACT) Study

Figures & data

Table 1 Patient Demographic and Clinical Characteristics

	Total N = 723	Budesonide/Formoterol MART n = 551	Fluticasone/Salmeterol Plus As-Needed SABA n = 172	p-value
Gender, n (%)
Male	348 (48.1)	269 (48.8)	79 (45.9)	0.508
Female	375 (51.9)	282 (51.2)	93 (54.1)
Age, years
Mean (SD)	56.3 (16.6)	55.3 (16.1)	59.4 (17.5)	0.004
Min–Max	11.5–93.5	14.2–93.5	11.5–90.3
Height, cm
Mean (SD)	160.8 (8.4)	161.1 (8.3)	159.7 (8.6)	0.064
Min–Max	136.0–193.0	136.0–183.0	140.0–193.0
Weight, Kg
Mean (SD)	64.5 (12.0)	64.9 (12.1)	63.3 (11.6)	0.137
Min–Max	37.5–113.0	37.5–113.0	41.0–100.0
BMI, Kg/m^2
Mean (SD)	24.9 (4.0)	25.0 (4.0)	24.8 (3.9)	0.611
Min–Max	15.6–42.0	16.0–42.0	15.6–40.1
Level of asthma control at enrollment, n (%)
Partly controlled	524 (72.5)	408 (74.0)	116 (67.4)	0.090
Uncontrolled	199 (27.5)	143 (26.0)	56 (32.6)
Medical events (within 3 months prior to enrollment)
Number of severe exacerbations
Mean (SD)	1.05 (2.99)	1.09 (3.23)	0.90 (2.02)	0.459
n (%)	236 (32.6)	169 (30.7)	67 (39.0)	0.043
Number of unscheduled clinical visits
Mean (SD)	0.35 (1.15)	0.33 (1.16)	0.42 (1.12)	0.370
n (%)	120 (16.6)	82 (14.9)	38 (22.1)	0.026
Number of emergency department visits
Mean (SD)	0.09 (0.35)	0.10 (0.37)	0.08 (0.27)	0.590
n (%)	58 (8.0)	44 (8.0)	14 (8.1)	0.948
Number of hospitalizations
Mean (SD)	0.03 (0.20)	0.03 (0.20)	0.04 (0.20)	0.444
n (%)	19 (2.6)	12 (2.2)	7 (4.1)	0.178

Note: Bold font indicates statistical significance.

Abbreviations: ACQ-5, five-item Asthma Control Questionnaire; BMI, body mass index; MART, anti-inflammatory reliever and maintenance therapy; SABA, short-acting β₂ agonist; SD, standard deviation.

Table 2 Summary of ACQ-5 Scores (Full Analysis Set)

	Total	Budesonide/Formoterol	Fluticasone/Salmeterol	p-value (Between Study Groups)*
Baseline
n	722	550	172
Mean (SD)	1.52 (1.11)	1.54 (1.06)	1.46 (1.28)
Week 4 (Days 28–34)
n	454	343	111
Mean (SD)	0.73 (0.87)	0.72 (0.85)	0.78 (0.92)	0.504
Mean (SD) change from baseline	−0.76 (1.12)	−0.78 (1.07)	−0.68 (1.26)
Weeks 12–16 (Days 84–111)
n	247	178	69
Mean (SD)	0.62 (0.78)	0.57 (0.74)	0.74 (0.86)	0.111
Mean (SD) change from baseline	−0.81 (1.18)	−0.83 (1.04)	−0.73 (1.50)
End of study
n	719	547	172
Mean (SD)	0.66 (0.84)	0.63 (0.80)	0.77 (0.95)	0.056
Mean (SD) change from baseline	−0.86 (1.15)	−0.91 (1.11)	−0.69 (1.27)

Note: *Two-sided t-test without adjustments.

Abbreviations: ACQ-5, five-item Asthma Control Questionnaire; SD, standard deviation.

Table 3 Asthma Control Status (Full Analysis Set)

	Total	Budesonide/Formoterol	Fluticasone/Salmeterol	p-value
Baseline
n	723	551	172	0.090^+
Partly controlled	524 (72.5%)	408 (74.0%)	116 (67.4%)
Uncontrolled	199 (27.5%)	143 (26.0%)	56 (32.6%)
Week 4 (Days 28–34)
n	454	343	111	0.194^+
Controlled	199 (43.8%)	156 (45.5%)	43 (38.7%)	0.213*
Partly controlled	221 (48.7%)	159 (46.4%)	62 (55.9%)
Uncontrolled	34 (7.5%)	28 (8.2%)	6 (5.4%)
Weeks 12–16 (Days 84–111)
n	250	181	69	0.183^+
Controlled	156 (62.4%)	119 (65.7%)	37 (53.6%)	0.077*
Partly controlled	82 (32.8%)	54 (29.8%)	28 (40.6%)
Uncontrolled	12 (4.8%)	8 (4.4%)	4 (5.8%)
End of study
n	723	551	172	0.014^+
Controlled	384 (53.1%)	309 (56.1%)	75 (43.6%)	0.004*
Partly controlled	299 (41.4%)	212 (38.5%)	87 (50.6%)
Uncontrolled	40 (5.5%)	30 (5.4%)	10 (5.8%)

Notes: Bold font indicates statistical significance. ⁺Comparison of asthma control status distribution between the two treatment groups. *Comparison of controlled rate between the two treatment groups.

Table 4 Forced Expiratory Volume in 1 Second (FEV₁) Results (Full Analysis Set)

(Unit: L)	Total	Budesonide/Formoterol	Fluticasone/Salmeterol	p-value
Baseline
n	305	252	53
Mean (SD)	1.77 (0.77)	1.82 (0.77)	1.54 (0.72)	0.016
Week 4 (Days 28–34)
n	60	45	15
Mean (SD)	1.71 (0.72)	1.83 (0.69)	1.34 (0.70)	0.021
Mean (SD) change from baseline	0.01 (0.37)	0.03 (0.35)	−0.06 (0.48)	0.560
p-value (change from baseline)	0.875	0.671	0.726
Weeks 12–16 (Days 84–111)
n	39	28	11
Mean (SD)	1.60 (0.86)	1.81 (0.88)	1.08 (0.54)	0.004
Mean (SD) change from baseline	−0.04 (0.37)	−0.02 (0.32)	−0.13 (0.56)	0.481
p-value (change from baseline)	0.538	0.803	0.555
End of study
N	86	66	20
Mean (SD)	1.72 (0.78)	1.85 (0.75)	1.31 (0.75)	0.006
Mean (SD) change from baseline	0.07 (0.38)	0.09 (0.36)	−0.01 (0.48)	0.420
p-value (change from baseline)	0.109	0.061	0.957

Note: Bold font indicates statistical significance.

Abbreviation: SD, standard deviation.

Table 5 Peak Expiratory Flow Rate (PEFR) Results (Full Analysis Set)

(Unit: L/min)	Total	Budesonide/Formoterol	Fluticasone/Salmeterol	p-value
Baseline
N	328	263	65
Mean (SD)	304.6 (123.4)	310.8 (126.0)	279.4 (109.7)	0.066
Week 4 (Days 28–34)
N	132	99	33
Mean (SD)	341.8 (134.4)	362.0 (141.0)	281.2 (89.8)	<0.001
Mean (SD) change from baseline	29.4 (89.2)	35.7 (87.1)	12.7 (94.1)	0.265
p-value (change from baseline)	0.002	0.001	0.498
Weeks 12–16 (Days 84–111)
N	86	62	24
Mean (SD)	323.5 (134.1)	347.3 (136.7)	262.2 (107.0)	0.008
Mean (SD) change from baseline	9.1 (77.5)	15.1 (73.2)	−5.6 (87.5)	0.344
p-value (change from baseline)	0.358	0.178	0.791
End of Study
N	179	135	44
Mean (SD)	333.0 (134.1)	349.8 (133.6)	281.4 (123.2)	0.003
Mean (SD) change from baseline	21.5 (73.1)	24.5 (67.8)	11.6 (89.2)	0.391
p-value (change from baseline)	0.001	<0.001	0.474

Note: Bold font indicates statistical significance.

Abbreviation: SD, standard deviation.

Table 6 Severe Exacerbations and Medical Resource Utilization: Patient- and Event-Based Rates (95% Confidence Intervals) per 100 Patient-Years (Full Analysis Set)

	Total N = 723	Budesonide/Formoterol n = 551	Fluticasone/Salmeterol n = 172
Exacerbations
Patient-based	23.8 (16.6–33.1)	26.4 (17.7–37.9)	16.1 (5.9–35.1)
Event-based	36.7 (27.6–47.9)	37.3 (26.8–50.7)	34.9 (18.6–59.8)
Unscheduled clinic visits (number)
Patient-based	16.3 (10.5–24.3)	19.1 (11.8–29.2)	8.1 (1.6–23.6)
Event-based	29.3 (21.2–39.4)	30.1 (20.7–42.2)	26.9 (12.9–49.4)
Emergency department visits (number)
Patient-based	2.7 (0.7–7.0)	1.8 (0.2–6.6)	5.4 (0.6–19.4)
Event-based	2.7 (0.7–7.0)	1.8 (0.2–6.6)	5.4 (0.6–19.4)
Hospitalizations (number)
Patient-based	3.4 (1.1–7.9)	3.6 (1.0–9.3)	2.7 (0.4–15.0)
Event-based	3.4 (1.1–7.9)	3.6 (1.0–9.3)	2.7 (0.4–15.0)
Oral corticosteroid treatment (number)
Patient-based	5.4 (2.3–10.7)	4.6 (1.5–10.6)	8.1 (1.6–23.6)
Event-based	8.2 (4.2–14.3)	5.5 (2.0–11.9)	16.1 (5.9–35.1)