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A single dose, randomised, placebo-controlled, double-blind, 5-way crossover (employing an incomplete block design), efficacy (including 24-h pulmonary function tests) and safety comparison of Tiotropium/BI 54903 FDC ethanolic inhalation solution via Respimat (doses of 1.23 µg/363.6 µg, 2.46 µg/363.6 µg or 4.93 µg/363.6 µg) versus free combination of Tiotropium aqueous inhalation solution via Respimat (doses of 0, 2.5 µg, 5 µg or 10 µg) plus BI 54903 ethanolic inhalation solution via Respimat (dose of 363.6 µg ) in patients with asthma.

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Trial Profile

A single dose, randomised, placebo-controlled, double-blind, 5-way crossover (employing an incomplete block design), efficacy (including 24-h pulmonary function tests) and safety comparison of Tiotropium/BI 54903 FDC ethanolic inhalation solution via Respimat (doses of 1.23 µg/363.6 µg, 2.46 µg/363.6 µg or 4.93 µg/363.6 µg) versus free combination of Tiotropium aqueous inhalation solution via Respimat (doses of 0, 2.5 µg, 5 µg or 10 µg) plus BI 54903 ethanolic inhalation solution via Respimat (dose of 363.6 µg ) in patients with asthma.

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 11 Mar 2017

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At a glance

  • Drugs BI 54903/tiotropium bromide (Primary) ; Ciclesonide; Tiotropium bromide
  • Indications Asthma
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim
  • Most Recent Events

    • 11 Mar 2017 New trial record
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