A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 microgram and 5 microgram) administered once daily in the afternoon via Respimat Inhaler for 12 weeks in patients 1 to 5 years old with persistent asthma

Trial Profile

A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 microgram and 5 microgram) administered once daily in the afternoon via Respimat Inhaler for 12 weeks in patients 1 to 5 years old with persistent asthma

Completed
Phase of Trial: Phase II/III

Latest Information Update: 01 Apr 2018

At a glance

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

    • 01 Apr 2018 Results of pooled data from vitro compared with nine clinical trial assessing PK exposure to tiotropium in preschool children with persistent asthmatic symptoms (using test VHC), were published in the Respiratory Medicine.
    • 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.
    • 06 Sep 2016 According to a Boehringer Ingelheim media release, safety data of this trial were presented at the European Respiratory Society (ERS) International Congress 2016.
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