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Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 3 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination With 5 Microgram Tiotropium Bromide (Delivered by the Respimat Inhaler) Compared With 5 Microgram Tiotropium Bromide Monoproduct (Delivered by the Respimat Inhaler) in Patients With COPD [chronic obstructive pulmonary disease].

Trial Profile

Randomised, Double-Blind, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Once Daily Treatment of 3 Doses of Orally Inhaled BI 1744 CL, Each in Fixed Dose Combination With 5 Microgram Tiotropium Bromide (Delivered by the Respimat Inhaler) Compared With 5 Microgram Tiotropium Bromide Monoproduct (Delivered by the Respimat Inhaler) in Patients With COPD [chronic obstructive pulmonary disease].

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Olodaterol/tiotropium bromide (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 06 Mar 2019 Primary endpoint (Trough FEV1 response [L] for fixed-dose combination of tiotropium 5 mug with olodaterol 10 mug) has been met, according to the results published in the Advances in Therapy
    • 06 Mar 2019 Primary endpoint (Trough FEV1 response [L] for fixed-dose combination of tiotropium 5 mug with olodaterol 5 mug) has not been met, according to the results published in the Advances in Therapy
    • 06 Mar 2019 Primary endpoint (Trough FEV1 response [L] for fixed-dose combination of tiotropium 5 mug with olodaterol 2 mug) has not been met, according to the results published in the Advances in Therapy
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