A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma

Trial Profile

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Efficacy and Safety of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (5 mcg/Day) Over 48 Weeks as add-on Controller Therapy on Top of Usual Care in Patients With Severe Persistent Asthma

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2018

At a glance

  • Drugs Tiotropium bromide (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms PrimoTinA-asthma-I
  • 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.
    • 05 Mar 2018 Results of post hoc analysis from five double-blind, placebo-controlled trials (GraziaTinA-asthma, MezzoTinA-asthma, PrimoTinA-asthma)presented at the 2018 Annual Meeting of the American Academy of Allergy, Asthma and Immunology
    • 24 May 2017 Results of a subgroup analysis assessing FEV1 responses in patients aged <65 and ≥65 years from four randomised trials (PrimoTinA-asthma and MezzoTinA-asthma) presented at the 113th International Conference of the American Thoracic Society
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