A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 µg and 5 µg Once Daily ) Delivered by the Respimat Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma

Trial Profile

A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 µg and 5 µg Once Daily ) Delivered by the Respimat Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 23 May 2018

At a glance

  • Drugs Tiotropium bromide (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms RubaTinA-asthma
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 23 May 2018 Results of an analysis comparing the changes in FEF25-75% and FEV1 following tiotropium add-on therapy with placebo in pediatric patients with symptomatic asthma using data from four phase III trials (VivaTinA-asthma, PensieTinA-asthma, CanoTinA-asthma and RubaTinA-asthma), presented at the 114th International Conference of the American Thoracic Society.
    • 24 May 2017 Results of clinical outcome data from five phase III studies (GraziaTinA-asthma, MezzoTinA-asthma-1, MezzoTinA-asthma-2, RubaTinA-asthma and PensieTinA-asthma) presented at the 113th International Conference of the American Thoracic Society
    • 24 May 2017 Results of pooled data analysis of 10 phase III studies (NinoTinA-asthma, CanoTinA-asthma,VivaTinA-asthma, RubaTinA-asthma,PensieTinA-asthma,GraziaTinA-asthma,MezzoTinA-asthma,PrimoTinA-asthma) assessing safety and tolerability presented at the 113th International Conference of the American Thoracic Society.
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