The efficacy of aclidinium/formoterol on lung function and symptoms in patients with COPD categorized by symptom status: a pooled analysis

Figures & data

Table 1 Baseline demographics and patient characteristics of less symptomatic and more symptomatic patients according to baseline E-RS and BDI

Demographic parameter	E-RS		BDI
	Less symptomatic (E-RS <10) n=1,172	More symptomatic (E-RS ≥10) n=2,164	Less symptomatic (BDI ≥7) n=1,519	More symptomatic (BDI <7) n=1,778
Age, mean (SD)	64.2 (8.3)	63.1 (8.5)	63.5 (8.3)	63.5 (8.6)
Sex, male, %	59.1	61.2	61.2	60.1
COPD severity (GOLD stages) (%)
Stage II (moderate)	68.5	53.1	66.8	51.4
Stage III (severe)	31.1	46.2	32.5	48.1
Current smoker, %	44.4	52.0	49.5	49.3
Smoking history, pack-years, mean (SD)	47.2 (24.4)	45.8 (24.2)	45.5 (23.7)	47.0 (24.8)
No exacerbations in previous	0.3 (0.6)	0.5 (0.9)	0.3 (0.7)	0.5 (0.9)
12 months, mean (SD)
Baseline FEV1, L, mean (SD)	1.4 (0.5)	1.4 (0.5)	1.5 (0.5)	1.3 (0.5)
Baseline FVC, L, mean (SD)	2.9 (0.9)	2.8 (0.9)	3.0 (0.9)	2.8 (0.8)
FEV1/FVC, %, mean (SD)	48.8 (10.4)	47.3 (10.9)	49.2 (10.5)	46.3 (10.9)
E-RS total score at baseline (SD)	5.7 (2.8)	16.3 (4.6)	10.3 (5.9)	14.5 (6.4)
BDI score at baseline (SD)	7.5 (2.1)	5.9 (2.0)	8.2 (1.4)	4.9 (1.4)

Abbreviations: BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global initiative for chronic Obstructive Lung Disease; SD, standard deviation.

Figure 1 One-hour morning postdose FEV₁ change from baseline in less symptomatic and more symptomatic patients with COPD at week 24.

Notes: Data are LS mean ± SE for the pooled ITT population; ***P<0.0001.
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FEV₁, forced expiratory volume in 1 second; FF, formoterol fumarate 12 µg; LS, least squares; ITT, intent-to-treat; SE, standard error.

Figure 2 Trough FEV₁ (1-hour morning predose) change from baseline in less symptomatic and more and symptomatic patients with COPD at week 24.

Notes: Data are LS mean ± SE for the pooled ITT population; *P<0.05; ***P<0.001.
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FEV₁, forced expiratory volume in 1 second; FF, formoterol fumarate 12 µg; ITT, intent-to-treat; LS, least squares; SE, standard error.

Figure 3 TDI focal score change from baseline in less symptomatic and more symptomatic patients with COPD at week 24.

Notes: Data are LS mean ± SE for the pooled ITT population; *P<0.05; ***P<0.001.
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FF, formoterol fumarate 12 µg; ITT, intent-to-treat; LS, least squares; SE, standard error; TDI, Transition Dyspnea Index.

Figure 4 E-RS total score change from baseline in less symptomatic and more symptomatic patients with COPD at week 24.

Notes: Data are LS mean ± SE for the pooled ITT population; *P<0.05; **P<0.01; ***P<0.001.
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FF, formoterol fumarate 12 µg; ITT, intent-to-treat; LS, least squares; SE, standard error.

Figure 5 Change from baseline in (A) early-morning and (B) nighttime symptom severity in less symptomatic and more symptomatic patients with COPD at week 24.

Notes: Data are LS mean ± SE for the pooled ITT population; *P<0.05; **P≤0.01; ***P<0.001.
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FF, formoterol fumarate 12 µg; ITT, intent-to-treat; LS, least squares; SE, standard error.

Figure 6 Change from baseline in early-morning limitation of activity in (A) the overall pooled population and (B) less symptomatic and more symptomatic patients with COPD.

Notes: Data are LS mean ± SE for the pooled ITT population; *P<0.05; **P<0.01; ***P<0.001.
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FF, formoterol fumarate 12 µg; ITT, intent-to-treat; LS, least squares; SE, standard error.

Figure 7 Rate of moderate or severe COPD exacerbations (HCRU criteria) in less symptomatic and more symptomatic patients at Week 24, (A) less symptomatic and more symptomatic defined by E-RS score, (B) less symptomatic and more symptomatic defined by BDI score.

Note: *P≤0.05; P=0.057 vs placebo in more symptomatic patients with BDI <7; Moderate or severe exacerbations are defined as exacerbations that require treatment with antibiotics or corticosteroids and those which result in hospitalization, respectively; Exacerbations data are RR (95% CI).
Abbreviations: AB, aclidinium bromide 400 µg; BDI, Baseline Dyspnea Index; CI, confidence interval; COPD, chronic obstructive pulmonary disease; E-RS, Evaluating Respiratory Symptoms; FF, formoterol fumarate 12 µg; HCRU, healthcare resource utilization; RR, rate ratio.