A Randomized, Double-Blind, Controlled, Parallel Group, 12-Week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 microg Once Daily With Open Label Tiotropium 18 microg Once Daily Versus Open Label Tiotropium 18 microg Once Daily in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease. [Estudio de 12 semanas de duración, aleatorizado, doble ciego, controlado, con grupos paralelos, para comparar la eficacia y seguridad de la combinación de 150 µg de indacaterol una vez al día con 18 µg de tiotropio abierto una vez al día frente a 18 µg de tiotropio abierto una vez al día en pacientes con enfermedad pulmonar obstructiva crónica de moderada a grave]

Trial Profile

A Randomized, Double-Blind, Controlled, Parallel Group, 12-Week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 microg Once Daily With Open Label Tiotropium 18 microg Once Daily Versus Open Label Tiotropium 18 microg Once Daily in Patients With Moderate-to-Severe Chronic Obstructive Pulmonary Disease. [Estudio de 12 semanas de duración, aleatorizado, doble ciego, controlado, con grupos paralelos, para comparar la eficacia y seguridad de la combinación de 150 µg de indacaterol una vez al día con 18 µg de tiotropio abierto una vez al día frente a 18 µg de tiotropio abierto una vez al día en pacientes con enfermedad pulmonar obstructiva crónica de moderada a grave]

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Feb 2013

At a glance

  • Drugs Indacaterol (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms INTRUST-1
  • Sponsors Novartis Pharmaceuticals
  • Most Recent Events

    • 18 May 2011 Results presented at the 107th International Conference of the American Thoracic Society.
    • 15 May 2011 Results presented at the 107th International Conference of the American Thoracic Society, according to a Novartis media release.
    • 12 Feb 2011 Primary endpoint 'Forced-expiratory-volume-in-1-second' has been met, according to a Novartis media release.
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