A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

Trial Profile

A Prospective, Multicenter, 12-week, Randomized Open-label Study to Evaluate the Efficacy and Safety of Glycopyrronium (50 Micrograms o.d.) or Indacaterol Maleate and Glycopyrronium Bromide Fixed-dose Combination (110/50 Micrograms o.d.) Regarding Symptoms and Health Status in Patients With Moderate Chronic Obstructive Pulmonary Disease (COPD) Switching From Treatment With Any Standard COPD Regimen

Completed
Phase of Trial: Phase IV

Latest Information Update: 08 Dec 2016

At a glance

  • Drugs Glycopyrrolate (Primary) ; Glycopyrrolate/indacaterol (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Therapeutic Use
  • Acronyms CRYSTAL
  • Sponsors Novartis
  • Most Recent Events

    • 08 Dec 2016 According to a Novartis media release, results of this trial support the 2017 GOLD recommendations.
    • 08 Dec 2016 Results from this trial were presented at the 2016 British Thoracic Society Winter Meeting, as reported in a Novartis media release.
    • 08 Dec 2016 Primary endpoint has been met. (Change from baseline on Transition Dyspnea Index (TDI) for groups: indacaterol maleate and glycopyrronium bromide FDC vs. long-acting bronchodilators (LABA or LAMA monotherapy)), as reported in a Novartis media release.
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