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A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat inhaler once daily in the evening over 12 weeks as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma

Trial Profile

A randomised, double-blind, placebo-controlled, parallel-group trial to evaluate efficacy and safety of tiotropium inhalation solution (2.5 mcg and 5 mcg) delivered via Respimat inhaler once daily in the evening over 12 weeks as add-on controller therapy on top of usual care in children (6 to 11 years old) with severe persistent asthma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Jan 2022

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At a glance

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