Trial Profile
A Phase III, Randomised, Double Blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy and Safety Over 48 Weeks of Orally Inhaled Tiotropium Bromide (2.5 µg and 5 µg Once Daily ) Delivered by the Respimat Inhaler in Adolescents (12 to 17 Years Old) With Moderate Persistent Asthma
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 07 Oct 2021
Price :
$35
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At a glance
- Drugs Tiotropium bromide (Primary)
- Indications Asthma
- Focus Registrational; Therapeutic Use
- Acronyms RubaTinA-asthma
- Sponsors Boehringer Ingelheim Pharmaceuticals
- 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
- 23 May 2018 Results of an analysis comparing the changes in FEF25-75% and FEV1 following tiotropium add-on therapy with placebo in pediatric patients with symptomatic asthma using data from four phase III trials (VivaTinA-asthma, PensieTinA-asthma, CanoTinA-asthma and RubaTinA-asthma), presented at the 114th International Conference of the American Thoracic Society.