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A 12-Week Treatment, Multi-Center, Randomized, Parallel Group, Blinded, Double Dummy Study to Compare the Efficacy and Safety of Indacaterol (150 microg o.d.) Delivered Via a SDDPI With Tiotropium (18 microg o.d.) Delivered Via a HandiHaler, in Patients With Moderate-to-Severe COPD.

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A 12-Week Treatment, Multi-Center, Randomized, Parallel Group, Blinded, Double Dummy Study to Compare the Efficacy and Safety of Indacaterol (150 microg o.d.) Delivered Via a SDDPI With Tiotropium (18 microg o.d.) Delivered Via a HandiHaler, in Patients With Moderate-to-Severe COPD.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2017

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At a glance

  • Drugs Indacaterol (Primary) ; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms INTENSITY
  • Sponsors Novartis

    • Most Recent Events

    • 24 May 2017 Results (n=8445) of a pooled analysis from 11 Phase III/IIIb indacaterol studies assessing the efficacy and safety of once-daily indacaterol 150 and 300 ug in elderly patients with moderate to severe COPD, published in the Respiratory Medicine.
    • 02 May 2016 Study is single blind in Italy as per EudraCT record. Other countries from EudraCT record and NCT source is reporting it as double blind.
    • 24 Mar 2012 Planned number of patients changed from 1568 to 1600 as reported by European Clinical Trials Database record.

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