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A 12 Week Treatment, Multi-Center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 microg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 microg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler.

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Trial Profile

A 12 Week Treatment, Multi-Center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 microg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 microg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2017

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At a glance

  • Drugs Indacaterol (Primary) ; Salmeterol (Primary)
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms INSIST
  • 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.
  • 30 Nov 2015 Discrepancy in dates: EudraCT reports global end date as 09 Oct 2015 where as NCT reports as 01 Oct 2009. Retained it as per NCT as it is a reliable source.
  • 25 Dec 2010 Additional trial investigator (Rai K) identified as reported by Clinical Trials Registry - India.

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