A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat Inhaler Once Daily in the Evening Over 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma

Trial Profile

A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (2.5 mcg and 5 mcg) Delivered Via Respimat Inhaler Once Daily in the Evening Over 48 Weeks in Children (6 to 11 Years Old) With Moderate Persistent Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 30 Sep 2017

At a glance

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

    • 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.
    • 24 May 2017 Results of pooled analysis from two phase III studies, presented at the 113th International Conference of the American Thoracic Society.
    • 16 Feb 2017 According to a Boehringer Ingelheim media release, based on efficacy and safety data from the Phase II and Phase III UniTinA-asthma clinical development program, the US FDA has approved the (sNDA) of SPIRIVA RESPIMAT under a priority review designation for the long-term, once-daily maintenance treatment of asthma in people age 6 and older. The FDA also granted pediatric exclusivity to SPIRIVA RESPIMAT.
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