Pneumologie 2015; 69 - P145
DOI: 10.1055/s-0035-1544685

Once-daily tiotropium Respimat add-on to ICS ± LABA improves control across asthma severities

O Schmidt 1, JM FitzGerald 2, H Kerstjens 3, P Paggiaro 4, K Ohta 5, M Ichinose 6, P Moroni-Zentgraf 7, M Engel 7, H Schmidt 8, E Bateman 9
  • 1KPPK GmbH, Pneumologische Facharztpraxis Koblenz
  • 2Institute for Heart and Lung Health, University of British Columbia
  • 3Department of Pulmonary Medicine and Tuberculosis, University of Groningen
  • 4Cardio-Thoracic and Vascular Department, University Hospital of Pisa
  • 5Tokyo National Hospital
  • 6Department of Respiratory Medicine, Tohoku University Graduate School of Medicine
  • 7TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH & Co. KG
  • 8Global Biometrics and Clinical Applications, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss
  • 9University of Cape Town

Background: Tiotropium Respimat added to ICS±LABA has been investigated across asthma severities. We present ACQ-7 responses from six Phase III randomised, double-blind, placebo-controlled, parallel-group trials in patients with symptomatic asthma.

Methods: Two 48-wk trials (PrimoTinA, NCT00772538/6984): 5µg added to ICS (≥800µg budesonide or equivalent [bud or eq])+LABA; two 24-wk trials (MezzoTinA, NCT01172808/2821): 5/2.5µg added to ICS (400 – 800µg bud or eq); 12-wk trial (GraziaTinA, NCT01316380): 5/2.5µg added to ICS (200 – 400µg bud or eq); 52-wk trial (CadenTinA, NCT01340209): 5/2.5µg added to ICS (400 – 800µg bud or eq). ACQ-7 responder rates were pre-specified in MezzoTinA, GraziaTinA and CadenTinA; ACQ-7 change from baseline (response) was pre-specified in PrimoTinA.

Results: ACQ-7 responder rate (n/N, (%)): PrimoTinA, wk 48: 5 µg 263/453 (58.1), placebo (pbo) 205/454 (45.2); MezzoTinA, wk 24: 5 µg 330/513 (64.3), 2.5 µg 332/515 (64.5), pbo 299/518 (57.7); GraziaTinA, wk 12: 5 µg 90/155 (58.1), 2.5 µg 91/154 (59.1), pbo 91/155 (58.7); CadenTinA, wk 52: 5 µg 87/114 (76.3), 2.5 µg 81/114 (71.1), pbo 41/56 (73.2). Adjusted mean response difference vs placebo Respimat±SE: PrimoTinA, 5µg –0.132 ± 0.049 (p = 0.007); MezzoTinA, 5µg –0.115 ± 0.043 (p = 0.008), 2.5µg –0.160 ± 0.043 (p < 0.001); GraziaTinA, 5µg 0.014 ± 0.067 (p = 0.835), 2.5µg 0.061 ± 0.067 (p = 0.362). Mean ACQ-7 (SD) in CadenTinA: 0.98 (0.63), 1.09 (0.72) and 0.99 (0.68) for 5µg, 2.5µg and pbo, respectively.

Conclusion: Once-daily tiotropium Respimat add-on to at least ICS maintenance therapy was associated with improved asthma control across severities.

Funding: Funding for this trial was provided by Boehringer Ingelheim. Editorial assistance was provided by Complete HealthVizion.

Presented at ERS congress 2014