Pneumologie 2018; 72(S 01): S32
DOI: 10.1055/s-0037-1619202
Sektion 7 – Klinische Pneumologie
Posterbegehung – Titel: Asthma II und Mukoviszidose
Georg Thieme Verlag KG Stuttgart · New York

Efficacy of once-daily tiotropium Respimat® in adults with asthma based on GINA steps 2 – 5

E Beck
1   IFG Institut für Gesundheitsförderung, Rüdersdorf
,
ER Bleecker
2   Center for Genomics and Personalised Medicine Research Pulmonary, Critical Care, Allergy and Immunologic Medicine, Wake Forest School of Medicine, Winston Salem, USA
,
R Buhl
3   University Hospital Mainz
,
M FitzGerald
4   Centre for Heart and Lung Health, Vancouver, Canada
,
E Meltzer
5   Allergy & Asthma Medical Group & Research Center, San Diego, USA
,
A de la Hoz
6   Boehringer Ingelheim Pharma GmbH & Co KG, Biberach
,
R Sigmund
6   Boehringer Ingelheim Pharma GmbH & Co KG, Biberach
,
HAM Kerstjens
7   University Medical Center, University of Groningen
› Author Affiliations
Further Information

Publication History

Publication Date:
21 February 2018 (online)

Also available at
 

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