Exacerbation recovery patterns in newly diagnosed or maintenance treatment-naïve patients with COPD: secondary analyses of TICARI 1 trial data

Figures & data

Figure 1 Study design.

Table 1 Baseline demographics and clinical characteristics

Characteristics	Total group (n=140)
Male/female, n (%)	63 (45.0)/77 (55.0)
Age, years, mean ± SD (range)	58.0±8.7 (40–83)
Age groups, n (%)
<55 years	60 (42.9)
55–65 years	52 (37.1)
>65 years	28 (20.0)
Race, n (%)
White	132 (94.3)
Black or African American	6 (4.3)
Other	2 (1.4)
Ethnicity, n (%)
Hispanic/Latino	2 (1.4)
Non-Hispanic/Latino	138 (98.6)
Body mass index, kg/m^2, mean ± SD	27.8±7.1
Ex-smoker/current smoker, n (%)	34 (24.3)/106 (75.7)
Smoking history
Pack-years,a mean ± SD	46.3±30.9
≥10 pack-years,a n (%)	132 (94.3)
Employed, n (%)	57 (40.7)
Post-bronchodilator spirometry (visit 1), mean ± SD
FEV1, L	1.78±0.64
FEV1, % predicted	62.71±19.10
FVC, L	3.20±0.97
FVC, % predicted	91.75±19.68
FEV1/FVC	0.56±0.10
Prior physician COPD diagnosis at study entry, n (%)	103 (73.6)
COPD duration in patients with known date of prior diagnosis (n/N=59/103), years, mean ± SD	1.05±1.75
GOLD stage (visit 1/visit 5b), n (%)
I (mild)	24 (17.1)/18 (13.7)
II (moderate)	76 (54.3)/67 (51.1)
III (severe)	36 (25.7)/29 (22.1)
IV (very severe)	4 (2.9)/5 (3.8)
Unclassifiedc	0 (0)/12 (9.2)
Patients with concomitant diagnosis,d n (%)	137 (97.9)
Hypertension	63 (45.0)
Hyperlipidemia	47 (33.6)
Depression	41 (29.3)
Anxiety	38 (27.1)
Gastroesophageal reflux disease	36 (25.7)
Osteoarthritis	31 (22.1)
CAT score, mean ± SD	23.8±7.6e
FACIT-SF – dyspnea score, mean ± SD	53.6±9.4f
FACIT-SF – functional limitation score, mean ± SD	51.6±9.8f

Notes:

a 1 pack-year represents 20 cigarettes per day for 1 year.

b Visit 5: n=131.

c At visit 1 (baseline), 12 patients had airflow obstruction determined by spirometry, but on repeat spirometry at visit 5, they did not meet the GOLD criteria for airflow obstruction and were therefore unclassified.

d Medical Dictionary for Drug Regulatory Activities (MedRA) version 15.1 preferred terms, most frequently reported concomitant diagnoses (≥20% of patients in either treatment group); patients may be included in more than one preferred term.

e n=98.

f n=139.

Abbreviations: CAT, COPD Assessment Test™; FACIT-SF, Functional Assessment of Chronic Illness Therapy–Short Form; FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SD, standard deviation.

Table 2 Pre- and post-bronchodilator pulmonary function and GOLD stage at visit 1 by exacerbation recovery pattern

Characteristics	Recovered without relapse (n=69)	Recovered then relapsed (n=41)	No recovery (n=30)
Pre-bronchodilator spirometry, mean ± SD
FEV1, L	1.62±0.62	1.55±0.60	1.87±0.70
FEV1, % predicted	57.32±19.52	56.11±19.75	63.60±20.47
FVC, L	2.95±0.98	2.89±1.04	3.27±0.94
FVC, % predicted	84.07±21.53	85.43±24.23	90.95±20.45
FEV1/FVC ratio	0.55±0.09	0.54±0.11	0.56±0.11
Post-bronchodilator spirometry, mean ± SD
FEV1, L	1.77±0.63	1.67±0.61	1.96±0.69
FEV1, % predicted	62.59±18.93	60.20±19.95	66.41±18.35
FVC, L	3.20±1.00	3.01±0.88	3.46±0.98
FVC, % predicted	91.51±20.50	89.17±18.77	95.82±18.92
FEV1/FVC ratio	0.55±0.09	0.55±0.11	0.56±0.11
GOLD stage, n (%)
I (mild)	10 (14)	6 (15)	8 (27)
II (moderate)	40 (58)	20 (49)	16 (53)
III (severe)	18 (26)	13 (32)	5 (17)
IV (very severe)	1 (1)	2 (5)	1 (3)

Abbreviations: FEV₁, forced expiratory volume in 1 second; FVC, forced vital capacity; GOLD, Global Initiative for Chronic Obstructive Lung Disease; SD, standard deviation.

Figure 2 Weekly mean ± SE of daily (A) EXACT scores and (B) number of rescue medication puffs.

Notes: Shaded area represents the presumed pre-event mean ± SE, based on week 12 data. Solid line in A represents the 5-point change from the initial assessment.
Abbreviations: EXACT, EXAcerbation of Chronic Pulmonary Disease Tool; SE, standard error.

Figure 3 Exacerbation recovery patterns.

Notes: Descriptive statistics (mean ± SD) for the CAT and FACIT – Short Form scores for dyspnea and functional limitation over time (A, C, and E, respectively) and change from baseline (B, D, and F, respectively). For the CAT, only patients with COPD diagnosis before study entry were assessed.
Abbreviations: CAT, COPD Assessment Test™; FACIT, Functional Assessment of Chronic Illness Therapy; SD, standard deviation.

Figure 4 Daily EXACT scores (mean ± SE).

Notes: (A) Patients who recovered without a subsequent relapse (n=69), (B) patients who recovered and then relapsed (n=41), and (C) patients who did not meet the symptom improvement rule for recovery (n=30).
Abbreviations: EXACT, EXAcerbation of Chronic Pulmonary Disease Tool; SE, standard error.