Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study

Figures & data

Figure 1 BEACON study design.

Abbreviation: od, once daily.

Table 1 Demographics and clinical characteristics of patients at baseline

	QVA149 (110/50 μg) N = 90	IND (150 μg) + GLY (50 μg) N = 103	Total N = 193
Age (years)	65.6 (7.28)	64.2 (7.40)	64.9 (7.36)
Sex, n (%)
Male	58 (64.4)	59 (57.3)	117 (60.6)
Female	32 (35.6)	44 (42.7)	76 (39.4)
Race, n (%)
Caucasian	90 (100)	103 (100)	193 (100)
Pre-bronchodilator FEV1 (% predicted)	45.1 (12.88)	44.4 (12.95)	44.7 (12.89)
Post-bronchodilator FEV1 (% predicted)	54.1 (12.27)	53.8 (12.85)	54.0 (12.55)
FEV1 reversibility (% increase)	22.7 (16.78)	24.4 (19.47)	23.6 (18.24)
Duration of COPD (years)	7.3 (5.03)	6.8 (4.83)	7.0 (4.92)
Severity of COPD (GOLD 2010), n (%)
Moderate	55 (61.1)	60 (58.3)	115 (59.6)
Severe	35 (38.9)	43 (41.7)	78 (40.4)
ICS use, n (%)
No	29 (32.2)	39 (37.9)	68 (35.2)
Yes	61 (67.8)	64 (62.1)	125 (64.8)
Smoking history, n (%)
Ex-smoker	53 (58.9)	62 (60.2)	115 (59.6)
Current smoker	37 (41.1)	41 (39.8)	78 (40.4)
Number of pack-years	41.6 (17.84)	39.2 (20.22)	40.3 (19.14)

Notes: All values in mean (SD) unless specified. FEV₁ reversibility is calculated as % increase of FEV₁ value after inhalation of bronchodilator. Pack-year is calculated by packs smoked per day × number of years as a smoker.

Abbreviations: IND+GLY, indacaterol and glycopyrronium; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; COPD, chronic obstructive pulmonary disease; GOLD, Global initiative for chronic Obstructive Lung Disease; ICS, inhaled corticosteroid; SD, standard deviation.

Figure 2 Patient disposition.

Abbreviation: IND+GLY, indacaterol and glycopyrronium.

Figure 3 Trough FEV₁ (L) at week 4.

Abbreviations: IND+GLY, indacaterol and glycopyrronium; FEV₁, forced expiratory volume in 1 second; CI, confidence interval.

Table 2 Daily total symptom score and rescue medication use over 4 weeks

Treatment	n	Baseline mean (SE)	LS mean	SE	Comparison	Treatment difference
						LS mean	SE	95% CI
Change from baseline in the daily total symptom score
QVA149 (110/50 μg) (N = 84)	84	5.25 (0.275)	−0.42	0.140	QVA149 –	0.07	0.161	(−0.24, 0.39)
IND (150 μg) + GLY (50 μg) (N = 97)	95	5.74 (0.295)	−0.49	0.130	(IND+GLY)
Change from baseline in the mean daily number of puffs of rescue medication
QVA149 (110/50 μg) (N = 84)	84	2.24 (0.266)	−0.45	0.124	QVA149 –	−0.04	0.159	(−0.35, 0.28)
IND (150 μg) + GLY (50 μg) (N = 97)	95	2.04 (0.265)	−0.42	0.113	(IND+GLY)

Abbreviations: IND+GLY, indacaterol and glycopyrronium; LS mean, least squares mean; SE, standard error; CI, confidence interval.

Figure 4 FEV₁ AUC_0–4 hours at day 1 and week 4.

Abbreviations: FEV₁, forced expiratory volume in 1 second; AUC, area under curve; IND+GLY, indacaterol and glycopyrronium; CI, confidence interval.

Figure 5 FEV₁ for the first 4 hours at week 4.

Abbreviations: IND+GLY, indacaterol and glycopyrronium; FEV₁, forced expiratory volume in 1 second.

Table 3 Most frequent AEs (at least 1% in any treatment group) by preferred term of patients

	QVA149 (110/50 μg) N = 90 n (%)	IND (150 μg) + GLY (50 μg) N = 103 n (%)
Patients with any AE(s)	23 (25.6)	26 (25.2)
Preferred term
Nasopharyngitis	7 (7.8)	6 (5.8)
COPD worsening	4 (4.4)	2 (1.9)
Cough	4 (4.4)	2 (1.9)
Chest discomfort	2 (2.2)	0
Influenza	2 (2.2)	1 (1.0)
Myalgia	2 (2.2)	0
Pneumonia	2 (2.2)	0
Aortic aneurysm	1 (1.1)	0
Breast pain	1 (1.1)	0
Depression	1 (1.1)	0
Diarrhea	1 (1.1)	1 (1.0)
Dysphonia	1 (1.1)	1 (1.0)
Dyspnea	1 (1.1)	2 (1.9)
Headache	1 (1.1)	1 (1.0)
Ligament injury	1 (1.1)	0

Abbreviations: IND+GLY, indacaterol and glycopyrronium; AEs, adverse events; COPD, chronic obstructive pulmonary disease.

Table 4 Number (%) of patients with newly occurring or worsening notable QTc values (according to Fridericia’s formula) and maximum increase from baseline on study treatment

According to Fridericia’s formula	QVA149 (110/50 μg) N = 90 n/N (%)	IND (150 μg) + GLY (50 μg) N = 103 n/N (%)
QTc > 450 ms	1/89 (1.1)	4/102 (3.9)
QTc > 480 ms	0/89	0/102
QTc > 500 ms	0/89	0/102
Maximum increase from baseline
30–60 ms	0/84	4/101 (4.0)
>60 ms	0/84	0/101

Abbreviations: IND+GLY, indacaterol and glycopyrronium; ms, milliseconds.