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A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 microgram and 5 microgram) administered once daily in the afternoon via Respimat Inhaler for 12 weeks in patients 1 to 5 years old with persistent asthma

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Trial Profile

A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 microgram and 5 microgram) administered once daily in the afternoon via Respimat Inhaler for 12 weeks in patients 1 to 5 years old with persistent asthma

Status: Completed
Phase of Trial: Phase II/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 NinoTinA-asthma
  • 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.
    • 16 May 2019 Results of pooled analysis assessing the safety and tolerability of tiotropium from a pooled population of paediatric (1 to 17 years) patients with symptomatic asthma published in the European Respiratory Journal
    • 19 Sep 2018 Results (n=1691) of pooled data from PensieTinA-asthma, NinoTinA-asthma, CanoTinA-asthma, VivaTinA-asthma trials assessing safety of tiotropium in paediatric patients by gender, presented at the 28th Annual Congress of the European Respiratory Society.

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