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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 (2.5 and 5 microgram Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 microgram Twice Daily) Over 24 Weeks in Moderate Persistent Asthma II

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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 (2.5 and 5 microgram Once Daily) Compared With Placebo and Salmeterol HFA MDI (50 microgram Twice Daily) Over 24 Weeks in Moderate Persistent Asthma II

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2019

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At a glance

  • Drugs Tiotropium bromide (Primary) ; Salmeterol
  • Indications Asthma
  • Focus Registrational; Therapeutic Use
  • Acronyms MezzoTinA-asthma-2; MezzoTinA-asthma-II
  • Sponsors Boehringer Ingelheim Pharmaceuticals; Pfizer

Most Recent Events

  • 30 Sep 2019 Results (n=2100) of subgroup analysis of two studies (NCT01172808 and NCT01172821) assessing Tiotropium Respimat as add-on therapy in patients with symptomatic asthma published in the Respiratory Medicine
  • 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 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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