The impact of indacaterol/glycopyrronium fixed-dose combination versus tiotropium monotherapy on lung function and treatment preference: a randomized crossover study – the FAVOR study

Figures & data

Figure 1 Study design.

Notes: During screening, patients received their current COPD treatment and were instructed to abstain from tiotropium inhalation on visit 3 (randomization). Inhaled corticosteroids were allowed to be taken throughout the study when started 30 days prior to screening visit.
Abbreviations: IND/GLY, indacaterol/glycopyrronium; o.d., once daily; V, visit.

Figure 2 Patient disposition (full analysis set).

Notes: ^aForty-three patients were randomized into the sequence 1 (IND/GLY – tiotropium) and 45 patients were randomized into sequence 2 (tiotropium – IND/GLY). Three patients randomized to the IND/GLY – tiotropium group were treated vice-versa (ie, tiotropium – IND/GLY). ^bOne patient discontinued due to adverse event in tiotropium – IND/GLY group after start of treatment period 2.
Abbreviation: IND/GLY, indacaterol/glycopyrronium.

Table 1 Demographic and baseline characteristics (full analysis set)

Variables	Total (N=88)
Age, years	65.0 (9.6)
Gender, n (%)
Men	57 (64.8)
Race, n (%)
Caucasian	87 (98.9)
BMI, kg/m^2	26.4 (4.8)
Smoking status, n (%)
Current smoker	45 (51.1)
Ex-smoker	43 (48.9)
FEV1 (% predicted) post-bronchodilator	57.7 (13.6)
CAT score	17.6 (5.4)
Duration of smoking, pack-years	38.0 (17.8)
Number of COPD exacerbations in the previous year, n (%)
1	15 (17.0)
0	73 (83.0)
Duration since first treatment with tiotropium, years	2.5 (2.8)
Duration of tiotropium therapy prior to study entry, n (%)
<0.5 year	20 (22.7)
0.5–1 year	15 (17.0)
≥1 year	53 (60.2)
Number of comorbidities, n (%)
1	21 (23.9)
2	11 (12.5)
3	10 (11.4)
>3	27 (30.7)
Severity of COPD (as per GOLD 2010), n (%)
Stage I	3 (3.4)
Stage II	53 (60.2)
Stage III	32 (36.4)
Severity of COPD (as per GOLD 2015),a n (%)
Group B	56 (63.6)
Group D	32 (36.4)

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

a None of the patients belonged to Groups A and C.

Abbreviations: BMI, body mass index; CAT, COPD assessment test; FEV₁, forced expiratory volume in 1 s; GOLD, Global Initiative for Chronic Obstructive Lung Disease.

Figure 3 FEV₁ (L) 1 h post-inhalation after 4 weeks of each treatment (full analysis set).

Note: Data are least square means ±95% CI.
Abbreviations: FEV₁, forced expiratory volume in 1 s; IND/GLY, indacaterol/glycopyrronium.

Table 2 Treatment preference after receiving both the treatments (full analysis set)

	IND/GLY – Tiotropium (N=40)	Tiotropium – IND/GLY (N=48)	Total (N=88)
Patient preference
IND/GLY	31 (81.6%)	28 (59.6%)	59 (69.4%)*
Tiotropium	7 (18.4%)	19 (40.4%)	26 (30.6%)
Not answered	2	1	3
Physicians’ preference
IND/GLY	36 (90.0%)	35 (74.5%)	71 (81.6%)**
Tiotropium	4 (10.0%)	12 (25.5%)	16 (18.4%)
Not answered	0	1	1

Notes: Data are absolute numbers (percentage) of patients.

* p=0.0004 and

** p<0.0001 (IND/GLY versus tiotropium).

Abbreviation: IND/GLY, indacaterol/glycopyrronium.

Figure 4 Very important/important subjective reasons cited by patients and physicians for a preference for IND/GLY or tiotropium (full analysis set).

Notes: Data are displayed as percentage of patients/physicians that rated the provided reasons from a 5-item scale (very important, important, neutral, unimportant, and very unimportant) as very important or important. Two patients and 1 physician did not answer the questionnaire.
Abbreviation: IND/GLY, indacaterol/glycopyrronium.

Figure 5 Patients very satisfied/satisfied with their treatment (full analysis set).

Notes: Data are displayed as percentage of patients that were very satisfied or satisfied with the medication in terms of the provided items. All patients answered the questionnaire with exception of 1 patient who discontinued the study.
Abbreviation: IND/GLY, indacaterol/glycopyrronium.

Figure 6 TSQM-9 questionnaire results by domain (full analysis set).

Notes: Data are least square mean (±95% CI) of TSQM-9 total scores by domain (effectiveness, convenience, and global satisfaction) determined after 4 weeks of treatment. *p=0.0001, **p=0.0035. All patients answered the questionnaire with exception of 1 patient who discontinued the study.
Abbreviations: IND/GLY, indacaterol/glycopyrronium; TSQM-9, Treatment Satisfaction Questionnaire for Medication.

Figure 7 Improvement in FEV₁ (L) 1 h post-inhalation based on medication preference (full analysis set).

Note: Data are in least square mean ±95% CI.
Abbreviations: FEV₁, forced expiratory volume in 1 s; IND/GLY, indacaterol/glycopyrronium.

Table 3 Incidences of TEAEs reported by ≥2.5% of patients in either group (safety analysis set)

System organ class	IND/GLY (N=88)		Tiotropium (N=88)
	Number of events, n	Number of patients, n (%)	Number of events, n	Number of patients, n (%)
Any TEAE	62	28 (31.8)	33	21 (23.9)
Respiratory, thoracic and mediastinal disorders	26	16 (18.2)	11	8 (9.1)
Gastrointestinal disorders	7	5 (5.7)	1	1 (1.1)
Cardiac disorders	6	3 (3.4)	1	1 (1.1)
Investigations	5	3 (3.4)	0	0
Nervous system disorders	9	6 (6.8)	3	2 (2.3)
Infections and infestations	4	4 (4.5)	7	6 (6.8)
Musculoskeletal and connective tissue disorders	1	1 (1.1)	3	3 (3.4)

Abbreviations: IND/GLY, indacaterol/glycopyrronium; TEAE, treatment emergent adverse event.