A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 mircog, 2.5 microg and 5 microg) Delivered Via Respimat Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma.

Trial Profile

A Phase II Randomised, Double-blind, Placebo-controlled Incomplete Crossover Trial With 4-week Treatment Periods to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution (Doses of 1.25 mircog, 2.5 microg and 5 microg) Delivered Via Respimat Inhaler Once Daily in the Evening in Children 6 to 11 Yrs Old With Moderate Persistent Asthma.

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Apr 2018

At a glance

  • Drugs Tiotropium bromide (Primary)
  • Indications Asthma
  • Focus Pharmacogenomic; Therapeutic Use
  • 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.
    • 18 May 2016 Results of five trials (n=1397) presented at the 112th International Conference of the American Thoracic Society
    • 20 Oct 2012 Planned number of patients changed from 101 to 104.
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