Effect of add-on therapy of tiotropium in COPD treated with theophylline

Figures & data

Figure 1 Study design.

Notes: ^†British Medical Research Council score. Combination therapy: theophylline with tiotropium.

Table 1 Characteristics of patients with COPD at baseline

	Theophylline-alone group (n = 30)	Combination group (n = 31)	p value
Age, yr ± SD	71.8 ± 8.1	68.4 ± 9.1	NS
Sex, Female/Male	2/28	1/30	NS
Smoking history, Pack-yr ± SD	66.7 ± 57.2	57.5 ± 31.5	NS
Current smoker, % patients	13 (44.3)	14 (45.2)	NS
Body mass index, kg/m^2	21.8 ± 3.6	22.6 ± 3.0	NS
Severity of disease, n (%)
Mild (stage I)	8 (26.7)	4 (12.9)	NS
Moderate (stage II)	12 (40.0)	13 (41.9)	NS
Severe (stage III)	10 (33.3)	14 (45.2)	NS
MRC dyspnoea score, mean ± SD	2.0 ± 1.1	2.0 ± 1.1	NS
FVC (L), mean ± SD	2.8 ± 0.9	3.0 ± 0.8	NS
FEV1/FVC (%), mean ± SD	49.8 ± 12.4	47.1 ± 12.6	NS
Pre-medications, n (%)
Theophylline	11 (36.7)	6 (19.4)	NS
Long-acting β2-agonist	4 (13.3)	1 (3.2)	NS
Short-acting β2-agonist	7 (23.3)	2 (6.5)	NS
Short-acting anticholinergic drug	2 (6.7)	2 (6.5)	NS
Inhaled corticosteroid	5 (16.7)	2 (6.5)	NS

Abbreviations: FEV₁, forced expiratory volume in one second; FVC, forced vital capacity; NS, not significant; SD, standard deviation.

Figure 2 Trial profile.

Figure 3 Changes in FVC and FEV₁ in the theophylline alone (white squares) and the combination therapy group (black squares). In a and b, absolute values of FVC and FEV₁ are shown. In c and d, percentage changes in FVC and FEV₁ from the baseline are shown.

Notes: *p < 0.05, **p < 0.01, ***p < 0.001 compared with baseline values. ^†p < 0.05 between two groups.
Abbreviations: FVC, forced vital capacity; FEV₁, forced expiratory volume in one second.

Figure 4 Changes in FVC and FEV₁ in the theophylline-alone (white squares, n = 17) and the combination therapy group (black squares, n = 25), in patients who did not receive regular treatment with theophylline at the time of screening. In a and b, absolute values of FVC and FEV₁ are shown. In c and d, percentage changes in FVC and FEV₁ from the baseline are shown.

Notes: *p < 0.05, **p < 0.01, ***p < 0.001 compared with the baseline values. ^†p < 0.05 between two groups.
Abbreviations: FVC, forced vital capacity; FEV₁, forced expiratory volume in one second.

Figure 5 Changes in VC, IC, PEFR, ⩒₅₀ and ⩒₂₅ at 8 weeks. Changes in VC, IC, PEFR, ⩒₅₀, and ⩒₂₅ at 8 weeks were analyzed in theophylline-alone (white bars, n = 26) and combination therapy (solid bars, n = 30) groups.

Notes: *p < 0.05 compared with screening values. ^†p < 0.05 between two groups.
Abbreviations: IC, inspiratory capacity; PEFR, peak expiratory flow rate; VC, vital capacity.

Figure 6 British Medical Research Council (MRC) scores 4 and 8 weeks after the addition of tiotropium. (a) MRC scores 4 and 8 weeks after the addition of tiotropium were analyzed in theophylline-alone (white bars, n = 29) and combination therapy (solid bars, n = 30) groups. (b) MRC scores 4 and 8 weeks after the addition of tiotropium were analyzed in 42 patients who were not receiving theophylline at the time of screening: theophylline-alone (white bars, n = 17) and combination therapy (solid bars, n = 25).

Notes: *p < 0.05, p < 0.01 compared with baseline values.