Efficacy and safety of once-daily glycopyrronium in predominantly Chinese patients with moderate-to-severe chronic obstructive pulmonary disease: the GLOW7 study

Figures & data

Figure 1 Study design.

Table 1 Demographics and baseline clinical characteristics (safety set)

	Glycopyrronium (n=305)	Placebo (n=154)
Age, years	64.6 (7.84)	65.0 (8.29)
Sex, n (%)
Male	294 (96.4)	145 (94.2)
Ethnicity, n (%)
Chinese	246 (80.7)	119 (77.3)
Indian	5 (1.6)	5 (3.2)
Filipino	27 (8.9)	13 (8.4)
Korean	27 (8.9)	17 (11.0)
Severity of COPD, n (%)
Moderate	150 (49.2)	82 (53.2)
Severe	155 (50.8)	72 (46.8)
COPD duration, years	4.5 (5.31)	4.3 (5.00)
COPD exacerbation history, n (%)
0 exacerbation	241 (79.0)	109 (70.8)
1 exacerbation	47 (15.4)	31 (20.1)
>2 exacerbations	17 (5.6)	14 (9.1)
ICS use, n (%)	198 (64.9)	86 (55.8)
Smoking history, n (%)
Ex-smoker	237 (77.7)	120 (77.9)
Current smoker	68 (22.3)	34 (22.1)
Duration of smoking, pack-years	38.3 (20.78)	38.3 (21.13)
Pre-bronchodilator FEV1, L	1.13 (0.379)	1.13 (0.383)
Pre-bronchodilator FEV1, % predicted	42.83 (12.055)	44.49 (12.848)
Post-bronchodilator FEV1, L	1.33 (0.400)	1.33 (0.394)
Post-bronchodilator FEV1, % predicted	50.20 (12.421)	51.88 (12.449)
FEV1 reversibility, % increase	18.89 (12.761)	18.82 (11.835)
Post-bronchodilator FEV1/FVC,%	42.72 (9.894)	44.03 (10.994)

Note: Data are mean (SD) unless otherwise stated.

Abbreviations: COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroid; SD, standard deviation.

Figure 2 Patients’ dispositions.

Figure 3 Improvement in trough forced expiratory volume in 1 second (FEV₁) on Day 1, Week 12 and Week 26.

Notes: Data are least square means (standard error); *P<0.001.

Figure 4 Forest plot of the treatment differences between glycopyrronium and placebo in trough forced expiratory volume in 1 second (FEV₁) by subgroups at Week 12.

Notes: All P-values are P<0.001 except female subgroup (P=0.023); N1, number of patients analyzed in the glycopyrronium group; N2, number of patients analyzed in the placebo group. Dotted line represents minimum clinically important difference in trough FEV₁ (100 mL).
Abbreviations: CI, confidence interval; COPD, chronic obstructive pulmonary disease; LSM, least square mean; ICS, inhaled corticosteroids.

Table 2 Improvement in lung function and reduction in rescue medication use and symptom score during the GLOW7 study

	Glycopyrronium	Placebo	Treatment difference (glycopyrronium versus placebo)
Peak FEV1, L
Day 1	1.38 (0.012)	1.18 (0.015)	0.193 (0.015)**
Week 12	1.35 (0.021)	1.14 (0.025)	0.207 (0.024)**
Week 26	1.31 (0.025)	1.11 (0.030)	0.196 (0.030)**
FEV1 AUC5min-4h, L
Day 1	1.31 (0.012)	1.12 (0.014)	0.194 (0.013)**
Week 12	1.29 (0.020)	1.08 (0.024)	0.206 (0.023)**
Week 26	1.24 (0.023)	1.05 (0.028)	0.197 (0.029)**
Trough FVC, L
Day 1	2.97 (0.026)	2.74 (0.030)	0.230 (0.029)**
Week 12	2.89 (0.035)	2.65 (0.041)	0.245 (0.036)**
Week 26	2.90 (0.038)	2.68 (0.044)	0.223 (0.039)**
Change from baseline in mean daily number of puffs	−0.77 (0.157)	−0.55 (0.186)	−0.23 (0.181)ns
Percentage of days with no rescue medication use	41.81 (2.785)	37.80 (3.206)	4.01 (2.835)ns
Change from baseline in mean daily total symptom score	−1.16 (0.143)	−0.85 (0.164)	−0.31 (0.146)*

Notes: Data are least square means (standard error);

** P<0.001;

* P<0.05;

ns not significant.

Abbreviations: AUC, area under the curve; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; SE, standard error.

Figure 5 Improvement (A) and percentage of patients with MCID (B) in SGRQ total score at Week 12 and Week 26.

Notes: ***P<0.001; **P<0.01; *P<0.05.

Abbreviations: LSM, least square mean; MCID, minimum clinically important difference; OR, odds ratio; SE, standard error; SGRQ, St George’s Respiratory Questionnaire.

Figure 6 Improvement (A) and percentage of patients with MCID (B) in TDI focal score at Week 12 and Week 26.

Note: *P<0.001.
Abbreviations: LSM, least square mean; MCID, minimum clinically important difference; OR, odds ratio; SE, standard error; TDI, Transition Dyspnea Index.

Figure 7 Kaplan–Meier plot of the time to first moderate or severe chronic obstructive pulmonary disease exacerbation.

Table 3 Summary of resource utilization over the 26 week treatment period

	Glycopyrronium (n=305)	Placebo (n=154)
Hospital admissions, n (%)
0	295 (96.7)	145 (94.2)
≥1	10 (3.3)	9 (5.8)
Mean (SD) total length of hospitalization, nights	14.1 (8.57)	13.9 (8.72)
ER visits, n (%)
0	302 (99.0)	152 (98.7)
≥1	3 (1.0)	2 (1.3)
Unscheduled doctor visit, n (%)
0	293 (96.1)	139 (90.3)
≥1	12 (3.9)	15 (9.7)

Abbreviations: SD, standard deviation; ER, emergency room.

Table 4 AEs ($1% in either treatment group), SAEs and discontinuations due to AEs and SAEs, n (%)

Preferred term	Glycopyrronium (n=305)	Placebo (n=154)
Patients with any AEs	133 (43.6)	73 (47.4)
SAEs	17 (5.6)	14 (9.1)
Death	4 (1.3)	1 (0.6)*
Discontinuation due to AE(s)	8 (2.6)	3 (1.9)
Discontinuation due to SAE(s)	5 (1.6)	3 (1.9)
Discontinuation due to non-SAE(s)	4 (1.3)	0
Most common AEs
Chronic obstructive pulmonary disease	58 (19.0)	39 (25.3)
Nasopharyngitis	37 (12.1)	15 (9.7)
Upper respiratory tract infection	18 (5.9)	12 (7.8)
Cough	5 (1.6)	3 (1.9)
Hypertension	5 (1.6)	3 (1.9)
Upper respiratory tract infection bacterial	5 (1.6)	4 (2.6)
Benign prostatic hyperplasia	4 (1.3)	1 (0.6)
Viral upper respiratory tract infection	4 (1.3)	1 (0.6)
Pneumonia	3 (1.0)	4 (2.6)
Dry mouth	2 (0.7)	2 (1.3)
Abdominal distension	1 (0.3)	3 (1.9)
Dysuria	1 (0.3)	2 (1.3)
Hyperglycemia	0	2 (1.3)

Note:

* The patient in the placebo group died in the follow-up period after the last dose of study drug.

Abbreviations: AE, adverse event; SAE, serious adverse event.