SOSPES: SPIRIVA® observational study measuring SGRQ score in routine medical practice in Central and Eastern Europe

Figures & data

Table 1 Patient baseline demography and disease characteristics (FAS population; N = 4435)

Variable	N	Baseline value
Mean age, years (SD)†	4364	62.6 (9.8)
Mean height, cm (SD)	4367	170.0 (8.3)
Mean weight, kg (SD)	4371	79.0 (15.6)
Mean BMI, kg/m^2 (SD)†	4360	27.3 (4.9)
Males, %†	3145	70.9
Current smokers, %†	1935	43.6
Exsmokers, %†	1873	42.2
Never smoked, %†	594	13.4
GOLD 1 (FEV1 >80% predicted), %‡	32	0.7
GOLD 2 (50% ≤ FEV1, <80% predicted), %‡	2140	48.3
GOLD 3 (30% ≤ FEV1, <50% predicted), %‡	1818	41.0
GOLD 4 (FEV1 <30% predicted), %‡	386	8.7
Any concomitant medication, %	1146	25.8
Mean SGRQ total score (SD)	4435	56.3 (20.3)
Mean SGRQ activity domain score (SD)	4435	62.3 (21.2)
Mean SGRQ impact domain score (SD)	4435	49.5 (23.2)
Mean SGRQ symptom domain score (SD)	4435	66.8 (21.6)

Notes:

† Data on age, height, weight, BMI, gender, smoking habits, and GOLD stage were not available for 1.6%, 1.5%, 1.4%, 1.7%, 0.6%, 0.7%, and 1.3% of patients, respectively;

‡ GOLD stage was determined by the physician.

Abbreviations: BMI, body mass index; FAS, full analysis set; FEV₁ forced expiratory volume in 1 second; GOLD, Global Initiative for Chronic Obstructive Lung Disease; N, number; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.

Figure 1 Disposition of study patients.

Abbreviations: FAS, full analysis set; N, total number; n, sample number; PPS, per-protocol set; SGRQ, St George’s Respiratory Questionnaire; TS, treated set.

Figure 2 Summary change from baseline in SGRQ total scores, activity domain, impact domain, and symptom domain (FAS population).

Notes: Summary change from baseline in (A) SGRQ total scores, (B) activity domain, (C) impact domain, and (D) symptom domain (FAS population).
Abbreviations: FAS, full analysis set; SGRQ, St George’s Respiratory Questionnaire.

Figure 3 Summary change from baseline in SGRQ total scores among COPD patients.

Notes: Summary change from baseline in SGRQ total scores among COPD patients in (A) participating countries, (B) current or exsmokers and nonsmokers, (C) compliant or noncompliant, and (D) with and without cardiac comorbidities. Bars show mean values of SGRQ scores. Number of patients is shown on bottom of bars. The negative number of capsules means that the patient had taken less capsules and vice versa. The patient is considered as noncompliant if the difference between the number of days and actual number of capsules taken between visit 1 and visit 2 or visit 2 and visit 3 is ≥10 capsules.
Abbreviations: COPD, chronic obstructive pulmonary disease; CR, Croatia; PL, Poland; RO, Romania; RU, Russian Federation; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire; SI, Slovenia; SK, Slovakia.

Table 2 Summary of patients SGRQ status and the association between characteristic of patients and relative improvement in SGRQ score within 6 months – FAS

Variable	Patient status, N (%)
	Improvement*	No change	Worsening*
Change from baseline to visit 3, N = 4335	3621 (83.5)	541 (12.5)	173 (4.0)
Change from baseline to visit 2, N = 4367	3257 (74.6)	907 (20.8)	203 (4.6)
Change from visit 2 to visit 3, N = 4267	2473 (58.0)	1468 (43.4)	326 (7.6)
	Improvement N = 3621	Worsening or no change, N = 714	RI (95% CI)	P
Males, %	71.8	69.7	1.02 (0.99, 1.06)	0.18
Mean age, years, SD	62.6 (9.8)	63.5 (9.8)	0.99 (0.987, 0.996)	<0.001
Patient aged >65 years	38.0	40.8	0.98 (0.97, 1.00)	0.06
Mean weight, kg, SD	79.0 (15.5)	79.4 (16.0)	0.99 (0.99, 1.00)	0.62
Mean BMI, kg/m^2, SD	27.3 (4.9)	27.5 (5.1)	1.00 (1.00, 1.00)	0.60
GOLD Stages 3 and 4, %	51.0	47.0	1.03 (0.99, 1.07)	0.16
Compliance, %	84.3	76.5	1.09 (1.04, 1.14)	<0.001
Patient with cardiac comorbidities	41.7	42.6	1.00 (0.99, 1.01)	0.70
Smokers and exsmokers, %	86.4	87.3	0.98 (0.89, 1.08)	0.70

Notes:

* Patients with increasing/decreasing of SGRQ score by 4 points or more were considered as improved/worsened. RI and its 95% CI based on multivariate analysis (ie, each other adjusted) controlling within-country correlations are presented.

Abbreviations: BMI, body mass index; CI, confidence interval; FAS, full analysis set; GOLD, Global Initiative for Chronic Obstructive Lung Disease; N, number; RI, relative improvement; SD, standard deviation; SGRQ, St George’s Respiratory Questionnaire.

Table 3 Summary of reported AEs (TS population; N = 4852)

	Number of AEs	Number (%) of patients
Any AE	306	182 (3.8)
Respiratory, thoracic, and mediastinal disorders	136	83 (1.71)
Gastrointestinal	67	56 (1.15)
Nervous system	38	26 (0.54)
Severe AEs	38	23 (0.5)
Study drug-related AEs	90	68 (1.4)
AEs leading to treatment discontinuation	23	14 (0.3)
Other significant AEsa	15	12 (0.2)
Any SAE	26	15 (0.3)
Hospitalizations	16	9 (0.2)
Fatal AEs	10	7 (0.1)

Note:

a AEs classified as “other significant” includes those nonserious and nonsignificant AEs with “action taken = discontinuation” or “action taken = reduced.”

Abbreviations: AE, adverse event; N, number; SAE, serious adverse event; TS, treated set.