Introduction:
Tiotropium Respimat® is well tolerated and efficacious as add-on therapy to maintenance
low-dose ICS to high-dose ICS/LABA in adults with symptomatic asthma.
Aims:
We examined if these clinical benefits were consistent across groups classified as
GINA Steps 2 – 5.
Methods:
Data were from 5 double-blind, placebo-controlled trials (patients 18 – 75 years)
of the effect of tiotropium Respimat® on peak (within 3h post-dose FEV1 (0 – 3h))
and trough (pre-dose) FEV1 response vs. placebo. GINA Guidelines Step grouping was
based on treatments in: GraziaTinA-asthma® (12wks, tiotropium 2.5 µg, 5 µg or placebo,
as 2 puffs QD, added-on to ICS 200 – 400 µg budesonide/equivalent), MezzoTinA-asthma®
(2 × 24wk trials, tiotropium, 2.5 µg or 5 µg, as 2 puffs QD, salmeterol 50 µg bid
or placebo added-on to ICS 400 – 800 µg budesonide/equivalent) and PrimoTinA-asthma®
(2 × 48wk trials, tiotropium 5 µg, as 2 puffs QD or placebo added-on to ICS ≥800 µg
budesonide/equivalent + LABA ± additional controller medications).
Results:
Baseline characteristics were balanced across treatment groups in each trial (N> 3400).
Tiotropium Respimat® provided improvements in peak and trough FEV1 across GINA Steps
2 – 5 vs. placebo (Table 1); safety profiles were similar between tiotropium and placebo
groups.
Tab. 1:
Changes in peak and trough FEV1 levels from baseline across GINA steps
|
FEV1 (0 – 3h) peak, adjusted mean change from baseline vs. placebo, mL (95% CI)
|
|
Treatment
|
GINA 2 (N = 1085)
|
GINA 3 (N = 1334)
|
GINA4 (N = 967)
|
GINA 5 (N = 80)
|
|
|
GraziaTinA-asthma*
‡
|
MezzoTinA-asthma*
‡†
|
MezzoTinA-asthma*
‡†
|
PrimoTinA-asthma
|
|
|
+ MezzoTinA-asthma9*
‡†
|
|
+ PrimoTinA-asthma*
‡†
|
|
|
|
(8-week data)
|
(24-week data)
|
(24-week data)
|
(48-week data)
|
|
Tio 2.5 µg
|
155 (103, 206)
|
235 (187, 283)
|
181 (35, 326)
|
NA
|
|
|
P< 0.0001
|
P< 0.0001
|
P= 0.0152
|
|
|
Tio 5 µg
|
135 (84, 187)
|
187 (139, 235)
|
111 (63, 159)
|
199 (39, 359)
|
|
|
P< 0.0001
|
P< 0.0001
|
P< 0.0001
|
P= 0.0151
|
|
FEV1 trough, adjusted mean change from baseline vs. placebo, mL (95% CI)
|
|
Tio 2.5 µg
|
116 (63, 170)
|
180 (128, 232)
|
165 (31, 300)
|
NA
|
|
|
P< 0.0001
|
P< 0.0001
|
P= 0.0163
|
|
|
Tio 5 µg
|
112 (58, 165)
|
131 (80, 183)
|
91 (47, 136)
|
142 (-4, 289)
|
|
|
P< 0.0001
|
P< 0.0001
|
P< 0.0001
|
P= 0.0571
|
|
‡Patients were symptomatic at screening; †Pooled data. CI = confidence interval; FEV = forced expiratory volume; NA = not applicable;
Tio = tiotropium.
|
Conclusion:
Addition of tiotropium Respimat® to maintenance therapy in adult asthma patients provides
significant and sustained improvements in lung function across GINA Steps 2 – 5.
The study was supported by Boehringer Ingelheim.
Previously submitted to the 27th Int. Cong. of the ERS, 2017
