Article Text

PDF
P156 Efficacy, safety and tolerability of once-daily tiotropium respimat® add-on therapy in children with moderate symptomatic asthma
  1. O Schmidt1,
  2. E Hamelmann2,
  3. C Vogelberg3,
  4. I Laki4,
  5. G El Azzi5,
  6. M Engel5,
  7. P Moroni-Zentgraf5,
  8. H Finnigan6,
  9. M Vandewalker7
  1. 1KPPK GmH, Koblenz, Germany
  2. 2Evangelisches Krankenhaus Bielefeld, and Allergy Centre of the Ruhr University, Bochum, Germany
  3. 3University Hospital Carl Gustav Carus, Technical University of Dresden, Dresden, Germany
  4. 4Department of Paediatric Pulmonology, Törökbálint, Hungary
  5. 5TA Respiratory Diseases, Boehringer Ingelheim Pharma GmbH and Co. KG, Ingelheim am Rhein, Germany
  6. 6Biostatistics and Data Sciences, Boehringer Ingelheim Ltd, Bracknell, UK
  7. 7Clinical Research of the Ozarks, Inc., Columbia, MO, USA

Abstract

Introduction and objectives A Phase II trial has shown that tiotropium Respimat® (tioR) is an effective, safe, and well-tolerated bronchodilator in patients aged 6–11 years with moderate symptomatic asthma.1 To further assess the efficacy and safety of once-daily tioR add-on therapy, a Phase III trial was carried out in patients aged 6–11 years with moderate symptomatic asthma.

Methods This 48-week, Phase III, randomised, double-blind, placebo-controlled, parallel-group study (CanoTinA-asthma®; NCT01634139) was performed in patients aged 6–11 years with moderate symptomatic asthma. Patients received once-daily tioR 5μg (2 puffs, 2.5 µg), tioR 2.5 μg (2 puffs, 1.25 µg) or placebo Respimat® (pboR; 2 puffs) as add-on to maintenance treatment of at least medium-dose inhaled corticosteroid (ICS) (200–400 µg budesonide or equivalent) alone or in combination with another controller medication. The primary end point was peak FEV1 within 3 hours post-dosing (FEV1(0–3 h)). Secondary end points included trough FEV1 (key end point), FEV1 area under the curve (AUC) (0–3 h), and peak FVC (0–3 h); all measured as response (change from baseline) at Week 24. Adverse events (AEs) were analysed descriptively.

Results Of 403 patients randomised, 401 were treated. Baseline demographics and disease characteristics were balanced between treatment groups. TioR 5 µg and 2.5 µg provided statistically significant improvements in lung function versus pboR at Week 24 (Table) with adjusted mean difference ± standard error peak FEV1 (0–3 h) improvements of 164 ± 31 ml (p < 0.0001) and 170 ± 31 ml (p < 0.0001), respectively. The frequency of patients with AEs was similar across treatment arms, with a low incidence of drug-related and serious AEs (Table); no deaths occurred. The most common AEs were asthma worsening/exacerbation (lower incidence in tioR 5µg and 2.5 µg [34.1% and 36.3%] vs pboR [43.5%]), decreased peak expiratory flow rate (21.5% and 23% vs 20.6%), nasopharyngitis (8.9% and 11.1% vs 9.9%) and respiratory tract infection (9.6% and 8.1% vs 12.2%).

Conclusion In patients aged 6–11 years with moderate symptomatic asthma, once-daily tioR add-on to ICS with or without other maintenance therapy significantly improves lung function compared with pboR. The safety profile of tioR was similar to that of pboR.

Reference

  1. Vogelberg C, et al. Respir Res 2015;16(1):20.

ReferencePlease refer to page A272 for declarations of interest in relation to abstract P156.

Abstract P156 Table 1

Peak FEV1(0–3 h), trough FEV1,FEV1 AUC(0–3 h), and Peak FVC(0–3 h) responses at Week 24 (full analysis set); and overall AEs in treated set

Statistics from Altmetric.com

Request permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.