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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2019

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At a glance

  • Drugs Tiotropium bromide (Primary)
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms PrimoTinA-asthma-I
  • Sponsors Boehringer Ingelheim Pharmaceuticals

    • Most Recent Events

    • 02 Jul 2019 Results of pooled analysis of 12 studies (NCT01634113, NCT01634139, NCT01634152, NCT01257230, NCT01277523, NCT01316380, NCT00350207, NCT01172808, NCT01172821, NCT01340209, NCT00772538 and NCT00776984) assessing safety of Tiotropium bromide as an add-on option to inhaled corticosteroids in pediatric and adult black or African-American patients with asthma, published in the Respiratory Medicine.
    • 23 May 2018 Results of a pooled analysis of two phase III trials (NCT00772538 and NCT00776984; n=912) assessing the effect of Tiotropium Respimat therapy on episodes of asthma worsening, presented at the 114th International Conference of the American Thoracic Society
    • 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.
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