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A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 microg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to Severe Persistent Asthma.

Trial Profile

A Phase III Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate Safety and Efficacy of Tiotropium Inhalation Solution Delivered Via Respimat Inhaler (2.5 and 5 microg Once Daily) Compared With Placebo Over 52 Weeks in Patients With Moderate to 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 Adverse reactions; Registrational
  • 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.
    • 01 Sep 2016 Results of safety analysis from pooled data (n= 3474) of this (NCT01340209) and six other trials (NCT01316380, NCT01172808, NCT01172821, NCT00772538, NCT00776984, NCT00350207), published in the Respiratory Medicine Journal.
    • 19 Jun 2014 Results published in the Boehringer Ingelheim Media Release.

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